FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX S CAPILLARY DIALYZER
MDR report key: 1033449
·
Received April 23, 2008
Report
- Report Number
- 9611369-2008-00312
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 20, 2008
- Report Date
- March 26, 2008
- Manufacturer
- GAMBRO DIALYSATOREN GMBH
- Product Code
- KDI
- PMA / PMN Number
- K982414
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES. THERE IS NO SAMPLE AVAILABLE FOR INVESTIGATION. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINTS BLOOD LEAK DURING THE TREATMENT. THE BLOOD LOSS WAS INSIGNIFICANT. NO PT HARM AND NO MEDICAL INTERVENTION WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYFLUX S CAPILLARY DIALYZER | KDI | GAMBRO DIALYSATOREN GMBH | POLYFLUX 21 S | 6-2801-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |