FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX R CAPILLARY DIALYZER
MDR report key: 1153145
·
Received September 4, 2008
Report
- Report Number
- 9611369-2008-00813
- Event Type
- Malfunction
- Date Received
- September 4, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 18, 2008
- Manufacturer
- GAMBRO DIAYLZATOREN GMBH
- Product Code
- MSF
- PMA / PMN Number
- K023615
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBRES. NO SAMPLE IS 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 COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. THE BLOOD FLOW RATE WAS 80ML/MIN, TMP, 90MHG. 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 R CAPILLARY DIALYZER | MSF | GAMBRO DIAYLZATOREN GMBH | POLYFLUX 17 R | 8-3552-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |