FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX LR CAPILLARY DIALYZER
MDR report key: 1111817
·
Received August 14, 2008
Report
- Report Number
- 9611369-2008-00743
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- July 10, 2008
- Report Date
- July 21, 2008
- Manufacturer
- GAMBRO DIALYSATOREN GMBH
- Product Code
- MSF
- PMA / PMN Number
- K023615
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES. THE SAMPLE HAS NOT ARRIVED FOR INVESTIGATION YET. THE ROOT CAUSE CAN BE DETERMINED AFTER INVESTIGATION. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY.
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 LR CAPILLARY DIALYZER | MSF | GAMBRO DIALYSATOREN GMBH | POLYFLUX 6 LR | 7-8101-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |