FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 970787
·
Received August 28, 2006
Report
- Report Number
- 9616240-2006-00431
- Event Type
- Malfunction
- Date Received
- August 28, 2006
- Manufacturer
- GAMBRO DASCO S.P.A., MONITOR DIVISION
- Product Code
- FII
- PMA / PMN Number
- k010805
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
FACILITY'S CHARGE NURSE STATED THAT THE PT HAD 30 POUNDS OF EXCESS FLUID, SO THE 227 ML EXCESSIVE FLUID REMOVAL DID NOT CAUSE THE PT DIFFICULTY. THE PT DID NOT REQUIRE ANY MEDICAL INTERVENTION FOR THE EXCESSIVE FLUID REMOVAL. ACCORDING TO THE CHARGE NURSE, IN 2006, THE PT WAS STILL IN THERAPY ON THE PRISMA MACHINE AND WAS NOT HAVING ANY DIFFICULTY. THE CUSTOMER WAS UNABLE TO IDENTIFY THE SERIAL # OF THE PRISMA MACHINE IN USE. PRISMASATE BAG MFR ALSO SUBMITTED REPORT 1051129-2006-00009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | FII | GAMBRO DASCO S.P.A., MONITOR DIVISION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |