FDA Adverse Event
Malfunction
Summary report: N
PRISMAFLEX
MDR report key: 1291143
·
Received January 3, 2009
Report
- Report Number
- 1291143
- Event Type
- Malfunction
- Date Received
- January 3, 2009
- Date of Event
- July 12, 2008
- Report Date
- January 3, 2009
- Manufacturer
- GAMBRO RENAL PRODUCTS, INC.
- Product Code
- MQS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
Narratives
Description of Event or Problem · 1
IN THE SUMMER OF LAST YEAR, RN WAS TAKING CARE OF PATIENT WITH CRRT PRISMAFLEX RUNNING CONTINUOUSLY. THERE WERE REPORTED "ACCESS PRESSURES" ISSUES WITH THE PATIENT AND ALL POSSIBLE NURSING INTERVENTIONS WERE CARRIED OUT TO ATTEMPT TO CORRECT PROBLEM. THE NURSE THEN REPORTED THAT THE MACHINE ALARMED WITH A MALFUNCTION OF THE EFFLUENT SCALE. THE MACHINE SHUT ITSELF DOWN AND WOULD NOT ALLOW ANY RETESTING TO OCCUR. THE MACHINE WAS SENT TO BIOMED FOR INSPECTION AND A REPLACEMENT PRISMAFLEX MACHINE WAS BROUGHT IN TO CONTINUE WITH THE ORDERED THERAPY.====================== MANUFACTURER RESPONSE FOR HEMODIALYSIS UNIT, PRISMAFLEX MACHINE======================GAMBRO ASSISTED WITH TESTING ON SITE AND SERVICED THE DEVICE AT THEIR LOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRISMAFLEX | HEMODIALYSIS MACHINE, CRRT/CVVH | MQS | GAMBRO RENAL PRODUCTS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |