FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX L CAPILLARY DIALYZER
MDR report key: 1023445
·
Received April 1, 2008
Report
- Report Number
- 9611369-2008-00204
- Event Type
- Malfunction
- Date Received
- April 1, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 6, 2008
- Manufacturer
- GAMBRO DIAYLZATOREN GMBH
- Product Code
- KDI
- PMA / PMN Number
- K040255
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBERS. THE SAMPLE HAS NOT ARRIVED FOR INVESTIGATION YET. THE ROOT CAUSE OF THIS EVENT CAN BE DETERMINED AFTER INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. QB=250ML/MIN, UF=0.8L/HR, VENOUS PRESSURE=165 MMHG. DIALYSATE PRESSURE= 155MMHG. 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 L CAPILLARY DIALYZER | KDI | GAMBRO DIAYLZATOREN GMBH | POLYFLUX 17 L | 7-4062-H-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |