SECTION 1
Complaints and Reports
Name and Surname^*
Name and Surname^*
Company name^*
Company name^*
Email^*
Email^*
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^*
Lot/s^*
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 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
Event description^*
Event description^*
Use description^*
Use description^*
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
SECTION 4.1
IF DOCUMENTAL DEFECT SELECTED
SECTION 4.2
IF AESTHETIC DEFECT SELECTED
SECTION 4.3
IF FUNCTIONAL DEFECT SELECTED
SECTION 4.3.1
IF CHEMICAL/THERMAL DISINFECTION = YES
SECTION 4.4
SECTION 5
Disposable device description – medical
SECTION 5.1
IF DOCUMENTAL DEFECT SELECTED
SECTION 5.2
IF AESTHETIC DEFECT SELECTED
SECTION 5.3
IF FUNCTIONAL DEFECT SELECTED
SECTION 5.3.1
IF YES:TREATMENT STOPPED
SECTION 5.3.1.1
IF Dialyzers SELECTED
SECTION 5.3.1.2
IF Plasmafiltration devices SELECTED
SECTION 5.3.1.3
IF Plasmafractionators SELECTED
SECTION 5.3.1.4
IF Hemoconcentration devices OR Hemofiltration devices OR Blood components concentrators SELECTED
SECTION 5.3.1.5
IF Leukocyte Adsorber SELECTED
SECTION 5.3.1.6
IF Oxygenation devices SELECTED
SECTION 5.3.1.7
IF Sets for infusion, perfusion and chemohyperthermia OR Sets and accessories for extracorporeal blood management SELECTED
SECTION 5.3.1.8
IF Catheters and accessories for urodynamics and gastrointestinal manometry SELECTED
SECTION 5.3.1.9
IF FLUID-EX SELECTED
SECTION 5.4
IF PACKAGING DEFECT SELECTED
SECTION 6
Active medical device/machines description
SECTION 6.1
IF DOCUMENTAL DEFECT SELECTED
SECTION 6.2
IF AESTHETIC DEFECT SELECTED
SECTION 6.3
IF FUNCTIONAL DEFECT SELECTED
SECTION 6.3.1
IF AcuSmart SELECTED
SECTION 6.3.1.1
AcuSmart – IF SCUF SELECTED
SECTION 6.3.1.2
AcuSmart – IF CVVH SELECTED
SECTION 6.3.1.3
AcuSmart – IF CVVHDF SELECTED
SECTION 6.3.1.4
AcuSmart – IF CVVHD SELECTED
SECTION 6.3.1.5
AcuSmart – IF ECCO2R SELECTED
SECTION 6.3.1.6
AcuSmart – IF ECCO2R+HF SELECTED
SECTION 6.3.1.7
AcuSmart – IF TPE SELECTED
SECTION 6.3.1.8
AcuSmart – IF HP SELECTED
SECTION 6.3.2
IF APHERcap SECLECTED
SECTION 6.3.2.1
APHERCAP – IF ECCO2R SELECTED
SECTION 6.3.2.2
APHERCAP – IF ECCO2R+HF SELECTED
SECTION 6.3.2.3
APHERCAP – IF HP SELECTED
SECTION 6.3.2.4
APHERCAP – IF HP+HF SELECTED
SECTION 6.3.3
IF AFERsmart SELECTED
SECTION 6.3.3.1
AFERsmart – IF HP SELECTED
SECTION 6.3.3.2
AFERsmart – IF PEX SELECTED
SECTION 6.3.3.3
AFERsmart – IF DF SELECTED
SECTION 6.3.3.4
AFERsmart – IF DFA SELECTED
SECTION 6.3.3.5
AFERsmart – IF SA SELECTED
SECTION 6.3.4
IF AFERsmart MS SELECTED
Treatment: Double Filtration Rheopheresis with Cartridge "PENTRACOR"
SECTION 6.3.5
IF AFERsmart Plus SELECTED
SECTION 6.3.5.1
AFERsmart Plus – IF HP SELECTED
SECTION 6.3.5.2
AFERsmart Plus – IF PEX SELECTED
SECTION 6.3.5.3
AFERsmart Plus – IF DF SELECTED
SECTION 6.3.5.4
AFERsmart Plus – IF DFA SELECTED
SECTION 6.3.5.5
AFERsmart Plus – IF SA SELECTED
SECTION 6.3.6
SECTION 6.3.6.1
Lipoprotein adsorption with DALI
SECTION 6.3.6.2
Plasma Fractionation with MONET
SECTION 6.3.6.3
Plasma separation for immunoadsorption therapy with ADAsorb
SECTION 6.3.7
IF CARDIOsmart SELECTED
Treatment: SCUF (Slow Continuous Ultra Filtration)
SECTION 6.3.8
IF VITAsmart SELECTED
SECTION 6.3.8.1
VITAsmart – IF Treatment of kidney perfusion SELECTED
SECTION 6.3.8.2
VITAsmart – IF Treatment of liver perfusion (portal vein) SELECTED
SECTION 6.3.8.3
VITAsmart – IF Treatment of liver perfusion (portal vein and hepatic artery) SELECTED
SECTION 6.3.9
IF DECAPsmart Plus SELECTED
SECTION 6.3.9.1
DECAPsmart Plus – IF ECCO2R SELECTED
SECTION 6.3.9.2
DECAPsmart Plus – IF ECCO2R+HF SELECTED
SECTION 6.3.9.3
DECAPsmart Plus – IF HP SELECTED
SECTION 6.3.9.4
DECAPsmart Plus – IF HP+HF SELECTED
SECTION 6.3.10
IF Equasmart SELECTED
SECTION 6.3.10.1
IF SCUF SELECTED
SECTION 6.3.10.2
IF CVVH SELECTED
SECTION 6.3.10.3
IF CVVHDF SELECTED
SECTION 6.3.10.4
IF CVVHD SELECTED
SECTION 6.3.10.5
IF CVVHPA SELECTED
SECTION 6.3.10.6
IF CO2 removal SELECTED
SECTION 6.3.10.7
IF Double Filtration SELECTED
SECTION 6.3.10.8
IF CVVH pre-post SELECTED
SECTION 6.3.10.9
IF CO2RH SELECTED
SECTION 6.3.10.10
IF TPE SELECTED
SECTION 6.3.10.11
IF HP SELECTED
SECTION 6.3.11
IF EstorFlow SELECTED
SECTION 6.3.11.1
IF Toraymyxin SELECTED
SECTION 6.3.11.2
IF ProLung SELECTED
SECTION 6.3.11.3
IF HP SELECTED
SECTION 6.3.12
IF Flexiper SELECTED
SECTION 6.3.12.1
IF HIPEC SELECTED
SECTION 6.3.12.2
IF HITHOC SELECTED
SECTION 6.3.12.3
IF ILP SELECTED
SECTION 6.3.13
IF Flowsmart SELECTED
Treatment: HP (Hemoperfusion)
SECTION 6.3.14
IF INTENSA SELECTED
SECTION 6.3.14.1
IF CVVH SELECTED
SECTION 6.3.14.2
IF CVVHDF SELECTED
SECTION 6.3.14.3
IF CVVHD SELECTED
SECTION 6.3.14.4
IF SCUF SELECTED
SECTION 6.3.14.5
IF SETS SELECTED
SECTION 6.3.14.6
IF CRRT EAD SELECTED
SECTION 6.3.14.7
IF HP SELECTED
SECTION 6.3.14.8
IF CO2 removal SELECTED
SECTION 6.3.15
IF Leucapher SELECTED
SECTION 6.3.15.1
IF HP SELECTED
SECTION 6.3.15.2
IF Leukocytopheresis treatment SELECTED
SECTION 6.3.16
IF Leukosmart SELECTED
Treatment: HP (Hemoperfusion)
SECTION 6.3.17
IF Lipidsmart SELECTED
Treatment: Lipoproteina Aferesi
SECTION 6.3.18
IF Plasmapher SELECTED
SECTION 6.3.18.1
IF PEX SELECTED
SECTION 6.3.18.2
IF DFPP SELECTED
SECTION 6.3.18.3
IF CF SELECTED
SECTION 6.3.18.4
IF HP SELECTED
SECTION 6.3.18.5
IF SA SELECTED
SECTION 6.3.19
IF Purifi SELECTED
Treatment: HP (Hemoperfusion)
SECTION 6.3.20
IF Veterinary Purifi SELECTED
Treatment: HP (Hemoperfusion)
SECTION 6.3.21
IF VETsmart SELECTED
SECTION 6.3.21.1
IF CVVH Selected
SECTION 6.3.21.2
IF CVVHD Selected
SECTION 6.3.21.3
IF PEX Selected
SECTION 6.3.21.4
IF HP Selected
SECTION 6.3.22
IF Dyno Smart SELECTED
SECTION 6.3.23
IF FlowZig SELECTED
SECTION 6.3.24
IF PicoFlow2 SELECTED
SECTION 6.3.25
IF PICO Smart SELECTED
SECTION 6.3.26
IF CarpeDiem SELECTED
SECTION 6.3.27
IF Kalos SELECTED
SECTION 6.4
IF PACKAGING DEFECT SELECTED
SECTION 7
Components
FINAL SECTION