FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX S CAPILLARY DIALYZER
MDR report key: 1153148
·
Received September 4, 2008
Report
- Report Number
- 9611369-2008-00816
- Event Type
- Malfunction
- Date Received
- September 4, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 18, 2008
- Manufacturer
- GAMBRO DIAYLZATOREN GMBH
- Product Code
- KDI
- PMA / PMN Number
- K982414
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE SHOWS LEAKAGE BETWEEN POTTING AND HOUSING. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT, AND THE CAUSE IS CONSIDERED CLOSED.
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 DIAYLZATOREN GMBH | POLYFLUX 21 S | 8-2804-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |