DISPONSABLE MEDICAL DEVICE
(DMD)
Name *
E-mail address *
Country *
Third party complaint reference (if any)
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Origin of the complaint - part 1
Organisation
Hospital/Clinic
Distributor
User
Company
Origin of the complaint - part 2
User
Doctor
Paramedic
QC
ALTRO
Other information regarding the Sender
Avanti
DEVICE DESCRIPTION
DISPONSABLE MEDICAL DEVICE (DMD)
Reference name
Code/s *
Lot/s *
Number of pieces Not-Compliant *
Other information regarding the DMD
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EVENT DESCRIPTION
DISPONSABLE MEDICAL DEVICE
Event date *
Defect Type
DOCUMENTAL
AESTHETIC
FUNCTIONAL
PACKAGING
ALTRO
DOCUMENTAL DEFECT
Defect type*
LABELING
IFU
USABILITY
Altro
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
AESTHETIC DEFECT
Defect type*
FLASHES/SCRATCHES
CONTAMINATION/FOREIGN BODY
MATERIAL INHOMOGENEITY
BLACK SPOT
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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
FUNCTIONAL DEFECT
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
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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
PACKAGING DEFECT
Defect type*
DEFECT/DAMAGE IN PRIMARY PACKAGING
DEFECT/DAMAGE OF SECONDARY PACKAGING
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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
Acknowledgment of the problem with respect to the treatment
Phase
Before: piece not installed
Installation / pretreatment
During treatment
Treatment finished Phase
Event Description*
Availability to send Non-Compliant devices
Medica SPA may not be able to respond to the complaint if it is not possible to analyze the Non-Compliant sample. Also send videos or photos if possible (send files at vigilance@medica.it).
Non-Compliant DMD
Yes, Contaminated
Yes, Not Contaminated
No
DMD same Lot
Yes, Contaminated
Yes, Not Contaminated
No
Other information regarding the Event
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DEVICE FAMILY
DISPONSABLE MEDICAL DEVICE
Line and accessories
FLUID-EX
Dialyzer
Hemofilter/Hemoconcentrator with or without line
PROTsmart
Plasma filter with or without line
Plasmafractionator
Leukocyte adsorber
Urodynamic/Manometry Catheter
Ultrafilter with or without line
Ultrafilter for dental unit waterline
Filter for washing/disinfecting medical devices
Line with oxygenator
CARPEDIEM
NEPHROS
SET CASSETTA
VAPOTHERM
ALTRO
Active Medical Device used (if applicable)
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TREATMENT
PARAMETERS
Treatment Description
Blood/Liquid Flow (mL/min)
IMMEDIATE
RESOLUTION
Description of the Actions taken following an Adverse Event
Patient status at the end of the treatment
Other Information
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ACTIONS REQUIRED
PARAMETERS
No action required
Defective Device Replacement
Whole Lot Replacement
Cause Analysis
Investigation report
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