SECTION 1
Complaints and Reports
Name and Surname^*
Name and Surname^*
Company name
Company name
Email^*
Email^*
Please do not add spaces or any extra characters before or after the email address, otherwise the message may not be delivered correctly.
Country^*
Country^*
Third party complaint reference (if any)
Third party complaint reference (if any)
Origin of the complaint – Organization
Origin of the complaint – Organization
Hospital/Clinic
Distributor
User
Company
Product name^*
Product name^*
Code/s^*
Code/s^*
Lot/s or Serial Number^*
Lot/s or Serial Number^*
Number of pieces Not-Compliant^*
Number of pieces Not-Compliant^*
Intended use of the product^*
Intended use of the product^*
SECTION 2
Complaints and Reports
What type of device do you wish to report?
What type of device do you wish to report?
Water Purification Filters
Medical Division Disposable
Medical Division Machines / Devices (AMD)
Components
SECTION 4
Water Purification Filter description
Number of days/months of use^*
Number of days/months of use^*
Liters of water processed^*
Liters of water processed^*
Description of the actions taken during the event^*
Description of the actions taken during the event^*
Event description^*
Event description^*
Use description^*
Use description^*
Event date ^*
Event date ^*
Event description
Defect type^*
Defect type^*
Documental
Aesthetic
Functional
Packaging
Other:
Acknowledgment of the event
Acknowledgment of the event
Phase
Before use
During installation
During use
After use
Availability to send Non-Compliant devices
Availability to send Non-Compliant devices
Non-Complaint Water Purification Filter
Yes, Contaminated
Yes, Not Contaminated
No
Availability to send Non-Compliant same lot devices
Availability to send Non-Compliant same lot devices
Water Purification Filter same lot
Yes, Contaminated
Yes, Not Contaminated
No
Other information regarding the event (if any)
Other information regarding the event (if any)
SECTION 4.1
IF DOCUMENTAL DEFECT SELECTED
Defect type^*
Defect type^*
Labeling
IFU
Usability
Other:
Did the event cause use problems?^*
Did the event cause use problems?^*
Yes: water purification stopped
No: water purification continued
Not Performed: the event prevented the use
SECTION 4.2
IF AESTHETIC DEFECT SELECTED
Defect type^*
Defect type^*
Scratches-signs-cracks
Material inhomogeneity
Stains – colature
Serigraphy
Foreign body
Burr-sharp edges
Other:
Did the event cause use problems?^*
Did the event cause use problems?^*
Yes: water purification stopped
No: water purification continued
Not Performed: the event prevented the use
SECTION 4.3
IF FUNCTIONAL DEFECT SELECTED
Inlet pressure (bar)^*
Inlet pressure (bar)^*
(Number)
Flow (lt/min)^*
Flow (lt/min)^*
(Number)
Liquid temperature (°C)^*
Liquid temperature (°C)^*
(Number)
Type of treated water^*
Type of treated water^*
Tap water
Other:
Upstream pretreatment^*
Upstream pretreatment^*
Yes
No
SECTION 4.3.0
IF FUNCTIONAL DEFECT SELECTED
Softner^*
Softner^*
Yes
No
Reverse osmosis plant^*
Reverse osmosis plant^*
Yes
No
SECTION 4.3.0.1
IF FUNCTIONAL DEFECT SELECTED
Pre-filter^*
Pre-filter^*
Yes
No
SECTION 4.3.0.2
IF FUNCTIONAL DEFECT SELECTED
Pre-filter mesh (pore) size (µm)^*
Pre-filter mesh (pore) size (µm)^*
(Number)
SECTION 4.3.0.3
IF FUNCTIONAL DEFECT SELECTED
Chemical/thermal disinfection (if any)
Chemical/thermal disinfection (if any)
Yes
No
SECTION 4.3.1
IF CHEMICAL/THERMAL DISINFECTION = YES
Duration (hours)
Duration (hours)
(Number)
Maximum temperature (°C)
Maximum temperature (°C)
(Number)
Pressure (Bar)
Pressure (Bar)
(Number)
SECTION 4.4
Defect type^*
Defect type^*
Defect/damage
Packaging error
Other:
Did the event cause problems?^*
Did the event cause problems?^*
Yes: water purification stopped
No: water purification continued
Not Performed: the event prevented the use
SECTION 5
Disposable device description – medical
Event date
Event date
Event description
Defect type^*
Defect type^*
Documental
Aesthetic
Functional
Packaging
Other:
Acknowledgment of the problem with respect to the treatment
Acknowledgment of the problem with respect to the treatment
Phase
Before: piece not installed
Installation / pretreatment
During treatment
Treatment finished
Event description^*
Event description^*
Availability to send Non-Compliant devices
Availability to send Non-Compliant devices
Non-Compliant DMD
Yes, Contaminated
Yes, Not Contaminated
No
Availability to send Non-Compliant devices
Availability to send Non-Compliant devices
DMD same Lot
Yes, Contaminated
Yes, Not Contaminated
No
Other information regarding the event
Other information regarding the event
SECTION 5.1
IF DOCUMENTAL DEFECT SELECTED
Defect type^*
Defect type^*
Labeling
IFU
Usability
Other:
Did the event cause treatment problems?^*
Did the event cause treatment problems?^*
Yes: treatment stopped
No: treatment continued until the end
Not Performed: the event prevented the start of the therapeutic procedure
SECTION 5.2
IF AESTHETIC DEFECT SELECTED
Defect type^*
Defect type^*
Scratches-signs-cracks
Material inhomogeneity
Stains – colature – rust
Serigraphy
Foreign body
Burr-sharp edges
Other:
Did the event cause treatment problems?^*
Did the event cause treatment problems?^*
Yes: treatment stopped
No: treatment continued until the end
Not Performed: the event prevented the start of the therapeutic procedure
SECTION 5.3
IF FUNCTIONAL DEFECT SELECTED
Defect type^*
Defect type^*
Biological
Component damaged before use
Incomplete component
Hemolysis
Incorrect device/component assembly
User interface
Kinking tubatisms
Device/Component obstruction
Blood/fluids loss
Performance lower than the declared specifications
Allergic reaction
Component breakdown during use
Debubbling
Filling
Unscrewing cap
Other:
Did the event cause treatment problems?^*
Did the event cause treatment problems?^*
Yes: treatment stopped
No: treatment continued until the end
Not Performed: the event prevented the start of the therapeutic procedure
SECTION 5.3.1
IF YES:TREATMENT STOPPED
Product category
Product category
Dialyzers
Plasmafiltration devices
Plasma fractionators
Hemoconcentration devices
Hemofiltration devices
Blood components concentrators
Leukocyte Adsorber
Oxygenation devices
Sets for infusion, perfusion and chemohyperthermia
Sets and accessories for extracorporeal blood management
Catheters and accessories for urodynamics and gastrointestinal manometry
FLUID-EX
Other:
SECTION 5.3.1.1
IF Dialyzers SELECTED
Patient Age
Patient Age
(Number)
Patient Weight
Patient Weight
(Number)
Patient status before treatment
Patient status before treatment
Treatment description
Treatment description
Blood flow (mL/min)
Blood flow (mL/min)
(Number)
Dialysate flow (mL/min)
Dialysate flow (mL/min)
(Number)
TMP (mmHg)
TMP (mmHg)
(Number)
Description of the actions taken following an adverse event
Description of the actions taken following an adverse event
Immediate resolution
Patient status at the end of the treatment
Patient status at the end of the treatment
Immediate resolution
Other information
Other information
Immediate resolution
SECTION 5.3.1.2
IF Plasmafiltration devices SELECTED
Patient Age
Patient Age
(Number)
Patient Weight
Patient Weight
(Number)
Patient status before treatment
Patient status before treatment
Treatment description
Treatment description
Blood flow (mL/min)
Blood flow (mL/min)
(Number)
Dialysate flow (mL/min)
Dialysate flow (mL/min)
(Number)
TMP (mmHg)
TMP (mmHg)
(Number)
Description of the actions taken following an adverse event
Description of the actions taken following an adverse event
Immediate resolution
Patient status at the end of the treatment
Patient status at the end of the treatment
Immediate resolution
Other information
Other information
Immediate resolution
SECTION 5.3.1.3
IF Plasmafractionators SELECTED
Patient Age
Patient Age
(Number)
Patient Weight
Patient Weight
(Number)
Patient status before treatment
Patient status before treatment
Treatment description
Treatment description
Plasma filter used
Plasma filter used
Plasma flow (mL/min)
Plasma flow (mL/min)
(Number)
Number of washes performed
Number of washes performed
(Number)
Amount of plasma treated
Amount of plasma treated
(Number)
Description of the actions taken following an adverse event
Description of the actions taken following an adverse event
Immediate resolution
Patient status at the end of the treatment
Patient status at the end of the treatment
Immediate resolution
Other information
Other information
Immediate resolution
SECTION 5.3.1.4
IF Hemoconcentration devices OR Hemofiltration devices OR Blood components concentrators SELECTED
Patient Age
Patient Age
Patient Weight
Patient Weight
Patient status before treatment
Patient status before treatment
Parameters
Parameters
Treatment description
Blood flow (mL/min)
Blood flow (mL/min)
Patient hemtocrit (%)
Patient hemtocrit (%)
Immediate resolution
Immediate resolution
Description of the actions taken following an adverse event
Patient status at the end of the treatment
Patient status at the end of the treatment
Other information
Other information
SECTION 5.3.1.5
IF Leukocyte Adsorber SELECTED
Patient Age
Patient Age
Patient Weight
Patient Weight
Patient status before treatment
Patient status before treatment
Parameters
Parameters
Treatment description
Blood flow (mL/min)
Blood flow (mL/min)
Treatment description
PLT concentration (10^3/ul)
PLT concentration (10^3/ul)
Treatment description
Anticoagulant used
Anticoagulant used
Treatment description
Anticoagulant flow (mL/min)
Anticoagulant flow (mL/min)
Treatment description
Immediate resolution
Immediate resolution
Description of the actions taken following an adverse event
Patient status at the end of the treatment
Patient status at the end of the treatment
Other information
Other information
SECTION 5.3.1.6
IF Oxygenation devices SELECTED
Treatment
Treatment
Organ
Liver
Kidney
Parameters
Parameters
Treatment description
Oxygen flow (mL/min)
Oxygen flow (mL/min)
Liquid Flow Perfusion (mL/min)
Liquid Flow Perfusion (mL/min)
PPO2 in the Perfusion Liquid (mmHg)
PPO2 in the Perfusion Liquid (mmHg)
Immediate Resolution
Immediate Resolution
Description of the actions taken following an adverse event
State of the organ at the end of the treatment
State of the organ at the end of the treatment
Other information
Other information
SECTION 5.3.1.7
IF Sets for infusion, perfusion and chemohyperthermia OR Sets and accessories for extracorporeal blood management SELECTED
Treatment
Treatment
Treatment description
Immediate Resolution
Immediate Resolution
Description of the actions taken following an adverse event
Other information
Other information
SECTION 5.3.1.8
IF Catheters and accessories for urodynamics and gastrointestinal manometry SELECTED
Treatment
Treatment
Treatment description
Immediate Resolution
Immediate Resolution
Description of the actions taken following an adverse event
Other information
Other information
SECTION 5.3.1.9
IF FLUID-EX SELECTED
Treatment
Treatment
Treatment description
Parameters
Parameters
Blood/liquid flow (mL/min)
Immediate Resolution
Immediate Resolution
Description of the actions taken following an adverse event
Patient status at the end of the treatment
Patient status at the end of the treatment
Other information
Other information
SECTION 5.4
IF PACKAGING DEFECT SELECTED
Defect type^*
Defect type^*
Defect/damage
Packaging error
Other:
Did the event cause treatment problems?^*
Did the event cause treatment problems?^*
Yes: treatment stopped
No: treatment continued until the end
Not Performed: the event prevented the start of the therapeutic procedure
SECTION 6
Active medical device/machines description
Event date
Event date
Defect type*
Defect type*
Documental
Aesthetic
Functional
Packaging
Other:
Acknowledgment of the problem with respect to the treatment
Acknowledgment of the problem with respect to the treatment
PHASE
Before: piece not installed
Installation / pretreatment
During treatment
Treatment finished
Event description^*
Event description^*
Availability to send Non-Compliant devices
Availability to send Non-Compliant devices
Non-compliant DMD
Yes, contaminated
Yes, not contaminated
No
Availability to send Non-Compliant devices
Availability to send Non-Compliant devices
DMD same Lot
Yes, contaminated
Yes, not contaminated
No
Other information regarding the event
Other information regarding the event
SECTION 6.1
IF DOCUMENTAL DEFECT SELECTED
Defect type^*
Defect type^*
Labeling
IFU
Other:
Did the event cause treatment problems?^*
Did the event cause treatment problems?^*
Yes: treatment stopped
No: treatment continued until the end
Not Performed: the event prevented the start of the therapeutic procedure
SECTION 6.2
IF AESTHETIC DEFECT SELECTED
Defect type^*
Defect type^*
Scratches-signs-cracks
Material inhomogeneity
Stains – colature – rust
Serigraphy
Foreign body
Burr-sharp edges
Other:
SECTION 6.3
IF FUNCTIONAL DEFECT SELECTED
Defect type^*
Defect type^*
Damaged component
Incomplete / missing component
Component out of specs
Performance lower than the declared specifications
Hardware malfunction
Software malfunction
Calibration
Usability
Performance not fitting for the intended use
Other:
Did the event cause treatment problems?^*
Did the event cause treatment problems?^*
Yes: treatment stopped
No: treatment continued until the end
Not Performed: the event prevented the start of the therapeutic procedure
Product category*^*
Product category*^*
AcuSmart
APHERcap
AFERsmart
AFERsmart MS
AFERsmart Plus
APRED
CARDIOsmart
VITAsmart
DECAPsmart Plus
Equasmart
EstorFlow
Flexiper
Flowsmart
INTENSA
Leucapher
Leukosmart
Lipidsmart
Plasmapher
Purifi
Veterinary Purifi
VETsmart
Dyno Smart
FlowZig
PicoFlow2
PICO Smart
CarpeDiem
Kalos
SECTION 6.3.1
IF AcuSmart SELECTED
Type of treatment*^*
Type of treatment*^*
SCUF (slow continuous ultrafiltration)
CVVH (continuous venous venous hemofiltration)
CVVHDF (continuous venous venous hemodiafiltration)
CVVHD (continuous venous venous hemodialysis)
ECCO2R
ECCO2R+HF
TPE (Therapeutic plasma exchange)
HP (hemoperfusion)
SECTION 6.3.1.1
AcuSmart – IF SCUF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Calcium and citrate pump flow, if set [mmol/l]
Calcium and citrate pump flow, if set [mmol/l]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.1.2
AcuSmart – IF CVVH SELECTED
Set weight loss [kg]
Set weight loss [kg]
Treatment duration [h:min]
Treatment duration [h:min]
Blood pump flow [ml/min]
Blood pump flow [ml/min]
Infusion pump flow [ml/min]
Infusion pump flow [ml/min]
Calcium and citrate pump flow, if set [mmol/l]
Calcium and citrate pump flow, if set [mmol/l]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.1.3
AcuSmart – IF CVVHDF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Dialysate pump flow [ml/min]
Dialysate pump flow [ml/min]
Calcium and citrate pump flow, if set [mmol/l]
Calcium and citrate pump flow, if set [mmol/l]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.1.4
AcuSmart – IF CVVHD SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Dialysate pump flow [ml/min]
Dialysate pump flow [ml/min]
Calcium and citrate pump flow, if set [mmol/l]
Calcium and citrate pump flow, if set [mmol/l]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.1.5
AcuSmart – IF ECCO2R SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.1.6
AcuSmart – IF ECCO2R+HF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Pre-substituion pump flow [ml/min]
Pre-substituion pump flow [ml/min]
Post-substituion pump flow [ml/min]
Post-substituion pump flow [ml/min]
Post-substituion pump flow [ml/min]
Post-substituion pump flow [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.1.7
AcuSmart – IF TPE SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Substituion/Plasma Pump Flow [ml/min]
Substituion/Plasma Pump Flow [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.1.8
AcuSmart – IF HP SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.2
IF APHERcap SECLECTED
Type of treatment
Type of treatment
ECCO2R (CO2 removal)
ECCO2R+HF (CO2 removal+hemoperfusion)
HP (hemoperfusion)
HP+HF (hemoperfusion+hemofiltration)
SECTION 6.3.2.1
APHERCAP – IF ECCO2R SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.2.2
APHERCAP – IF ECCO2R+HF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]
Infusion pump flow [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.2.3
APHERCAP – IF HP SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.2.4
APHERCAP – IF HP+HF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]
Infusion pump flow [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.3
IF AFERsmart SELECTED
Type of treatment^*
Type of treatment^*
HP (hemoperfusion)
PEX (plasma exchange)
DF (double filtration rheopheresis)
DFA (double filtration rheopheresis adsorption)
SA (rheopheresis selective apheresis)
SECTION 6.3.3.1
AFERsmart – IF HP SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood volume to be treated [l]^*
Blood volume to be treated [l]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.3.2
AFERsmart – IF PEX SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.3.3
AFERsmart – IF DF SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.3.4
AFERsmart – IF DFA SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.3.5
AFERsmart – IF SA SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.4
IF AFERsmart MS SELECTED
Treatment: Double Filtration Rheopheresis with Cartridge "PENTRACOR"
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood volume [l]^*
Blood volume [l]^*
Plasma volume [l]^*
Plasma volume [l]^*
Cycle volume [ml]^*
Cycle volume [ml]^*
Cycles number ^*
Cycles number ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Plasma flow [%]^*
Plasma flow [%]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.5
IF AFERsmart Plus SELECTED
Type of treatment^*
Type of treatment^*
HP (hemoperfusion)
PEX (plasma exchange)
DF (double filtration plasmapheresis)
DFA (double adsorption filtration)
SA (selective apheresis)
SECTION 6.3.5.1
AFERsmart Plus – IF HP SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Total recirculated blood [ml]^*
Total recirculated blood [ml]^*
Plasma volume [l]^*
Plasma volume [l]^*
Blood pump flow [ml/min]
Blood pump flow [ml/min]
Citrate, if set: Citrate flow [%QB]
Citrate, if set: Citrate flow [%QB]
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.5.2
AFERsmart Plus – IF PEX SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Plasma balance [%]^*
Plasma balance [%]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infused Plasma [ml]^*
Infused Plasma [ml]^*
Removed plasma [ml]^*
Removed plasma [ml]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Citrate, if set: Citrate flow [%QB]
Citrate, if set: Citrate flow [%QB]
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.5.3
AFERsmart Plus – IF DF SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Plasma balance [%]^*
Plasma balance [%]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Treated plasma [ml]^*
Treated plasma [ml]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Citrate, if set: Citrate flow [%QB]
Citrate, if set: Citrate flow [%QB]
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.5.4
AFERsmart Plus – IF DFA SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Plasma percentage [%]^*
Plasma percentage [%]^*
Treated plasma [ml]^*
Treated plasma [ml]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Citrate, if set: Citrate flow [%QB]
Citrate, if set: Citrate flow [%QB]
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.5.5
AFERsmart Plus – IF SA SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Plasma balance [%]^*
Plasma balance [%]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Citrate, if set: Citrate flow [%QB]
Citrate, if set: Citrate flow [%QB]
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.6
Type of treatment^*
Type of treatment^*
Lipoprotein adsorption with DALI
Plasma Fractionation with MONET
Plasma separation for immunoadsorption therapy with ADAsorb
SECTION 6.3.6.1
Lipoprotein adsorption with DALI
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood target volume ^*
Blood target volume ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
ACD flow [ml/min] mode^*
ACD flow [ml/min] mode^*
AUTO
RATIO
DALI parameters
DALI parameters
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.6.2
Plasma Fractionation with MONET
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood target volume^*
Blood target volume^*
Plasma target volume^*
Plasma target volume^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Plasma pump flow [ml/min]
Plasma pump flow [ml/min]
MONET parameters
MONET parameters
If set, ACD flow [ml/min] mode
If set, ACD flow [ml/min] mode
AUTO
RATIO
If set, heparin mode: [ml/l] if continuous or [ml] if at bolus
If set, heparin mode: [ml/l] if continuous or [ml] if at bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.6.3
Plasma separation for immunoadsorption therapy with ADAsorb
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Plasma target volume^*
Plasma target volume^*
Initial blood pump flow [ml/min]^*
Initial blood pump flow [ml/min]^*
Plasma pump ratio [%]^*
Plasma pump ratio [%]^*
ADASORB parameters
ADASORB parameters
If set, ACD flow [ml/min] mode
If set, ACD flow [ml/min] mode
AUTO
RATIO
If set, heparin mode: [ml/l] if continuous or [ml] if at bolus
If set, heparin mode: [ml/l] if continuous or [ml] if at bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.7
IF CARDIOsmart SELECTED
Treatment: SCUF (Slow Continuous Ultra Filtration)
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion flow [ml/min]^*
Infusion flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.8
IF VITAsmart SELECTED
Type of treatment^*
Type of treatment^*
Treatment of kidney perfusion
Treatment of liver perfusion (portal vein)
Treatment of liver perfusion (portal vein and hepatic artery)
SECTION 6.3.8.1
VITAsmart – IF Treatment of kidney perfusion SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow 1 [ml/min]^*
Blood pump flow 1 [ml/min]^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.8.2
VITAsmart – IF Treatment of liver perfusion (portal vein) SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow 1 [ml/min]^*
Blood pump flow 1 [ml/min]^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.8.3
VITAsmart – IF Treatment of liver perfusion (portal vein and hepatic artery) SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow 1 [ml/min]^*
Blood pump flow 1 [ml/min]^*
Blood pump flow 2 [ml/min]^*
Blood pump flow 2 [ml/min]^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.9
IF DECAPsmart Plus SELECTED
Type of treatment^*
Type of treatment^*
ECCO2R (CO2 removal)
ECCO2R+HF (CO2 removal+hemofiltration)
HP (hemoperfusion)
HP+HF (hemoperfusion+hemofiltration)
SECTION 6.3.9.1
DECAPsmart Plus – IF ECCO2R SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.9.2
DECAPsmart Plus – IF ECCO2R+HF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.9.3
DECAPsmart Plus – IF HP SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.9.4
DECAPsmart Plus – IF HP+HF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10
IF Equasmart SELECTED
Type of treatment^*
Type of treatment^*
SCUF (Slow Continuous Ultra Filtration)
CVVH (Continuous Veno Venous Hemofiltration)
CVVHDF (Continuous Veno-Venous Hemodiafiltration)
CVVHD (Continuous Veno-Venous Hemodyalisis)
CVVHPA (Continuous Veno-Venous Hemofiltration with Plasma Adsorber)
CO2 removal
Double Filtration
CVVH pre-post
CO2RH
TPE (Therapeutic Plasma Exchange)
HP (hemoperfusion)
SECTION 6.3.10.1
IF SCUF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.2
IF CVVH SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.3
IF CVVHDF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.4
IF CVVHD SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.5
IF CVVHPA SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Ultrafiltration pump flow [ml/min]^*
Ultrafiltration pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.6
IF CO2 removal SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]
Infusion pump flow [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.7
IF Double Filtration SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.8
IF CVVH pre-post SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Ultrafiltration pump flow [ml/min]^*
Ultrafiltration pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.9
IF CO2RH SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.10
IF TPE SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.10.11
IF HP SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.11
IF EstorFlow SELECTED
Type of treatment^*
Type of treatment^*
Toraymyxin
ProLung
HP (hemoperfusion)
SECTION 6.3.11.1
IF Toraymyxin SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.11.2
IF ProLung SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
CO2 flow [set]
CO2 flow [set]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.11.3
IF HP SELECTED
Treatment duration [h:min]^*
Treatment duration [h:min]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.12
IF Flexiper SELECTED
Type of treatment^*
Type of treatment^*
HIPEC
HITHOC
ILP
SECTION 6.3.12.1
IF HIPEC SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Heater temperature [°C]^*
Heater temperature [°C]^*
Patient’s T1 temperature [°C]^*
Patient’s T1 temperature [°C]^*
Patient cavity volume [ml]^*
Patient cavity volume [ml]^*
Patient Volume Balance [ml]^*
Patient Volume Balance [ml]^*
Patient recirculation flow [ml/min]
Patient recirculation flow [ml/min]
Reservoir Volume [ml]
Reservoir Volume [ml]
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.12.2
IF HITHOC SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Heater temperature [°C]^*
Heater temperature [°C]^*
Patient’s T1 temperature [°C]^*
Patient’s T1 temperature [°C]^*
Patient cavity volume [ml]^*
Patient cavity volume [ml]^*
Patient Volume Balance [ml]^*
Patient Volume Balance [ml]^*
Patient recirculation flow [ml/min]^*
Patient recirculation flow [ml/min]^*
Reservoir Volume [ml]
Reservoir Volume [ml]
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.12.3
IF ILP SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Heater temperature [°C]^*
Heater temperature [°C]^*
Patient’s T1 temperature [°C]^*
Patient’s T1 temperature [°C]^*
Patient Volume Balance [ml]^*
Patient Volume Balance [ml]^*
Flow [ml/min]^*
Flow [ml/min]^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.13
IF Flowsmart SELECTED
Treatment: HP (Hemoperfusion)
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.14
IF INTENSA SELECTED
Type of treatment^*
Type of treatment^*
CVVH (Continuous Veno-Venous Hemofiltration)
CVVHDF (Continuous Veno-Venous Hemodiafiltration)
CVVHD (continuous venous venous hemodialysis)
SCUF (slow continuous ultrafiltration)
SETS (Sequential Extracorporeal Therapy in Sepsis)
CRRT EAD (Enhanced Adsorption Dialysis)
HP (hemoperfusion)
CO2 removal (ProLUNG Meter)
SECTION 6.3.14.1
IF CVVH SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
POST pump flow[ml/min]^*
POST pump flow[ml/min]^*
PRE pump flow [ml/min]^*
PRE pump flow [ml/min]^*
Calcium and citrate pump flow, if set [ml/min]
Calcium and citrate pump flow, if set [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Set filter
Set filter
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.14.2
IF CVVHDF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
POST pump flow[ml/min]^*
POST pump flow[ml/min]^*
PRE pump flow [ml/min]^*
PRE pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Calcium and citrate pump flow, if set [ml/min]
Calcium and citrate pump flow, if set [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Set filter^*
Set filter^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.14.3
IF CVVHD SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Calcium and citrate pump flow, if set [ml/min]
Calcium and citrate pump flow, if set [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Set filter^*
Set filter^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.14.4
IF SCUF SELECTED
Set weight loss [kg]^*
Set weight loss [kg]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Calcium and citrate pump flow, if set [ml/min]
Calcium and citrate pump flow, if set [ml/min]
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Set filter^*
Set filter^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.14.5
IF SETS SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Set filter^*
Set filter^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.14.6
IF CRRT EAD SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Set filter^*
Set filter^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.14.7
IF HP SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.14.8
IF CO2 removal SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Set air flow [l/min]^*
Set air flow [l/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Set filter^*
Set filter^*
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.15
IF Leucapher SELECTED
Type of treatment^*
Type of treatment^*
HP (Hemoperfusion)
Leukocytopheresis treatment
SECTION 6.3.15.1
IF HP SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Blood volume to be treated [l]^*
Blood volume to be treated [l]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.15.2
IF Leukocytopheresis treatment SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Blood volume to be treated [l]^*
Blood volume to be treated [l]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.16
IF Leukosmart SELECTED
Treatment: HP (Hemoperfusion)
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Blood volume to be treated [l]^*
Blood volume to be treated [l]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.17
IF Lipidsmart SELECTED
Treatment: Lipoproteina Aferesi
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Citrate pump flow [ml/min]^*
Citrate pump flow [ml/min]^*
Blood volume to be treated [l]^*
Blood volume to be treated [l]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.18
IF Plasmapher SELECTED
Type of treatment^*
Type of treatment^*
PEX (Plasma Apheresis)
DFPP (Rheopheresis Double Filtration)
CF (Cascade Filtration)
HP (Hemoperfusion)
SA (Rheopheresis Selective Apheresis)
SECTION 6.3.18.1
IF PEX SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Suction pump flow [ml/min]^*
Suction pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.18.2
IF DFPP SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Suction pump flow [ml/min]^*
Suction pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.18.3
IF CF SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Suction pump flow [ml/min]^*
Suction pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.18.4
IF HP SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Suction pump flow [ml/min]^*
Suction pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.18.5
IF SA SELECTED
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Plasma volume to be treated [l]^*
Plasma volume to be treated [l]^*
Suction pump flow [ml/min]^*
Suction pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Plasma pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.19
IF Purifi SELECTED
Treatment: HP (Hemoperfusion)
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Total recirculated blood [ml]^*
Total recirculated blood [ml]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.3.20
IF Veterinary Purifi SELECTED
Treatment: HP (Hemoperfusion)
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Weight [kg]^*
Weight [kg]^*
Total recirculated blood [ml]^*
Total recirculated blood [ml]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Cartridge^*
Cartridge^*
50 ml
150 ml
300 ml
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
SECTION 6.3.21
IF VETsmart SELECTED
Type of treatment^*
Type of treatment^*
CVVH (Continuous Veno-Venous Hemofiltration)
CVVHD (Continuous Veno-Venous Hemodyalisis)
PEX (Plasma exchange)
HP (Hemoperfusion)
SECTION 6.3.21.1
IF CVVH Selected
Weight loss [g]^*
Weight loss [g]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Infusion pump flow [ml/min]^*
Ultrafiltration pump flow [ml/min]^*
Ultrafiltration pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
SECTION 6.3.21.2
IF CVVHD Selected
Weight loss [g]^*
Weight loss [g]^*
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
SECTION 6.3.21.3
IF PEX Selected
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Removed volume [ml]^*
Removed volume [ml]^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
SECTION 6.3.21.4
IF HP Selected
Treatment duration [h:min] ^*
Treatment duration [h:min] ^*
Blood pump flow [ml/min]^*
Blood pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Dialysate pump flow [ml/min]^*
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
Heparin anticoagulant flow, if set: [ml/h] if continuous or [ml] if bolus
SECTION 6.3.22
IF Dyno Smart SELECTED
Operating system of the used PC
Operating system of the used PC
Windows 10
Windows 11
Other:
Installed application version
Installed application version
Capillary pump channels
Capillary pump channels
4
8
Compressor
Compressor
Yes
No
Exam Type
Exam Type
Esophageal
Anorectal
Both
Catheter extractor present
Catheter extractor present
Yes
No
Connection with the acquisition unit
Connection with the acquisition unit
Bluetooth
Cable
Flow cell connection
Flow cell connection
Bluetooth
Cable
Bluetooth type
Bluetooth type
Integrated into the PC
Original key
Other:
Number of pressure channels
Number of pressure channels
Pressure module
Pressure module
SAU-MD-U
SAU-PRS
SAU-LG
Reporting program
Reporting program
WORD
OPENOFFICE
Other:
EMG channel
EMG channel
Yes
No
EMG type
EMG type
SAU-EMG
SAU-EMG/LS
SECTION 6.3.23
IF FlowZig SELECTED
Do you use built-in BLUETOOTH or external USB key?
Do you use built-in BLUETOOTH or external USB key?
Bluetooth
USB
Operating system of the used PC
Operating system of the used PC
Windows 10
Windows 11
Other:
Exam mode
Exam mode
Automatic
Manual
Reporting program
Reporting program
Word
Openoffice
Other:
SECTION 6.3.24
IF PicoFlow2 SELECTED
Cell type
Cell type
Bluetooth
Cable
Exam mode
Exam mode
Automatic
Manual
Installed software version
Installed software version
SECTION 6.3.25
IF PICO Smart SELECTED
Connection with the acquisition unit
Connection with the acquisition unit
Bluetooth
USB
Flow cell connection
Flow cell connection
Bluetooth
Cable
Bluetooth type
Bluetooth type
Integrated into the PC
Original key
Other:
Operating system of the used PC
Operating system of the used PC
Installed application version
Installed application version
Number of pressure channels
Number of pressure channels
Pressure module
Pressure module
SAU-MD-U
SAU-PRS
SAU-LG
Catheter extractor
Catheter extractor
Yes
No
Reporting program
Reporting program
Word
Openoffice
Other:
EMG channel
EMG channel
Yes
No
EMG type
EMG type
SAU-EMG
SAU-EMG/LS
SAU-EMG/LN
SECTION 6.3.26
IF CarpeDiem SELECTED
Is there an error in the packaging?
Is there an error in the packaging?
Yes
No
Is there an error in the labeling?
Is there an error in the labeling?
Yes
No
Is there an error in the installed SW version?
Is there an error in the installed SW version?
Yes
No
Are there any marks/scratches? If yes, where?
Are there any marks/scratches? If yes, where?
Yes
No
Is there a HW malfunction? If yes, which component is involved?
Is there a HW malfunction? If yes, which component is involved?
Yes
No
Is there an error in the documentation sent?
Is there an error in the documentation sent?
Yes
No
Testing failed? If yes, which element is involved?
Testing failed? If yes, which element is involved?
Yes
No
SECTION 6.3.27
IF Kalos SELECTED
which recipe (SW customization) is present on the device?^*
which recipe (SW customization) is present on the device?^*
B01 VETSMART
B02 BLOODH
B02 BLOODH65
C01 PLASMA
Other:
What is the set temperature? [°C]
What is the set temperature? [°C]
Is there an alarm? If yes, which one?
Is there an alarm? If yes, which one?
Yes
No
Description of the actions taken in case of adverse event
Description of the actions taken in case of adverse event
Other information
Other information
SECTION 6.4
IF PACKAGING DEFECT SELECTED
Defect type^*
Defect type^*
Defect/damage
Labelling
Packaging error
Missing component
Did the event cause treatment problems?*
^*
Did the event cause treatment problems?*
^*
Yes: treatment stopped
No: treatment continued until the end
Not Performed: the event prevented the start of the therapeutic procedure
SECTION 7
Components
What kind of problem was encountered?
What kind of problem was encountered?
What kind of resolution was applied?
What kind of resolution was applied?
FINAL SECTION
Materials upload
Materials upload
Upload here all the materials needed to better understand the reported problem (photos, videos, etc)
Add file
This type of file isn’t allowed
The file size must be up to 10 MB
Materials upload
Materials upload
Upload here all the materials needed to better understand the reported problem (photos, videos, etc)
Add file
This type of file isn’t allowed
The file size must be up to 10 MB
Materials upload
Materials upload
Upload here all the materials needed to better understand the reported problem (photos, videos, etc)
Add file
This type of file isn’t allowed
The file size must be up to 10 MB
Actions required
Actions required
Request to the Supplier
No action required
Defective device replacement
Whole lot replacement
Cause analysis
Investigation report
Edit documentation
Other: