FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 805190
·
Received December 15, 2006
Report
- Report Number
- 9616240-2006-00504
- Event Type
- Malfunction
- Date Received
- December 15, 2006
- Manufacturer
- GAMBRO DASCO S.P.A., MONITOR DIVISION
- Product Code
- KDI
- PMA / PMN Number
- k010805
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE PT DID NOT SUFFER AN INJURY, NOR DID THE PT REQUIRE MEDICAL INTERVENTION. ACCORDING TO THE FACILITY, THE EXCESSIVE FLUID REMOVAL WAS 4000CC OVER A 2 HR TIMEFRAME. FACILITY'S NURSE HAD FAILED TO BREAK THE FRANGIBLE PIN IN THE DIALYSATE BAG. THEREFORE DURING TREATMENT, THE PRISMA MACHINE PULLED THE FLUID AMOUNT PROGRAMMED FOR THE DIALYSATE FROM THE PT AS OPPOSED TO FROM THE DIALYSATE BAG AS INTENDED. THE NURSE INVOLVED IN THIS INCIDENT WAS RETRAINED ON THE USE OF DIALYSATE BAG AND THE PRISMA MACHINE. SOLUTION BAG MFR REPORT# 1051129-2006-00014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | KDI | GAMBRO DASCO S.P.A., MONITOR DIVISION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |