FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX S CAPILLARY DIALYZER
MDR report key: 1002732
·
Received February 27, 2008
Report
- Report Number
- 9611369-2008-00155
- Event Type
- Malfunction
- Date Received
- February 27, 2008
- Date of Event
- January 24, 2008
- Report Date
- January 31, 2008
- Manufacturer
- GAMBRO DIALYSATOREN GMBH
- Product Code
- KDI
- PMA / PMN Number
- K982414
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IF CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. THERE WAS INSIGNIFICANT BLOOD LOSS. NO MEDICAL INTERVENTION WAS NEEDED. NO SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYFLUX S CAPILLARY DIALYZER | KDI | GAMBRO DIALYSATOREN GMBH | POLYFLUX 21 8 | 7-2811-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |