FDA Adverse Event
Malfunction
Summary report: N
PRISMAFLEX
MDR report key: 1595433
·
Received January 18, 2010
Report
- Report Number
- 1595433
- Event Type
- Malfunction
- Date Received
- January 18, 2010
- Date of Event
- December 20, 2009
- Report Date
- January 18, 2010
- Manufacturer
- GAMBRO RENAL PRODUCTS, INC.
- Product Code
- MQS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
WHILE CHANGING THE EFFLUENT DRAINAGE BAG, THE COMPUTER SCREEN ON THE PRISMAFLEX CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) MACHINE FROZE, CAUSING A SCALE MALFUNCTION THAT SHUT OFF THE BLOOD PUMP. I WAS UNABLE TO RESTART THE BLOOD PUMP AFTER ATTEMPTING TO "RETEST" THE SCALE FUNCTION SEVERAL TIMES. THE PATIENT LOST APPROXIMATELY 200 CC'S OF BLOOD REMAINING IN THE SYSTEM. THIS FILTER HAD BEEN UP AND RUNNING ONLY 15 HOURS PRIOR TO THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRISMAFLEX | HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACMENT THERAPY | MQS | GAMBRO RENAL PRODUCTS, INC. | * | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |