FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX S CAPILLARY DIALYZER
MDR report key: 1002731
·
Received February 27, 2008
Report
- Report Number
- 9611369-2008-00154
- Event Type
- Malfunction
- Date Received
- February 27, 2008
- Date of Event
- December 21, 2007
- 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. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THE MOMENT. THE INVESTIGATION WILL BE STARTED AS SOON THE SAMPLES ARE ON HAND.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. BFR: 250ML/MIN, DFR: 600ML/MIN. 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 14 S | 7-2529-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |