FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX LR CAPILLARY DIALYZER
MDR report key: 1030401
·
Received April 16, 2008
Report
- Report Number
- 9611369-2008-00302
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Date of Event
- January 25, 2008
- Report Date
- March 26, 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. 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
CUSTOMER COMPLAINTS BLOOD LEAK DURING 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 LR CAPILLARY DIALYZER | MSF | GAMBRO DIALYSATOREN GMBH | POLYFLUX 8 LR | 7-8204-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |