FDA Adverse Event
Malfunction
Summary report: N
CVVH, BLOOD PUMP
MDR report key: 2454051
·
Received January 30, 2012
Report
- Report Number
- 2454051
- Event Type
- Malfunction
- Date Received
- January 30, 2012
- Date of Event
- December 27, 2011
- Report Date
- January 24, 2012
- Manufacturer
- GAMBRO RENAL PRODUCTS, INC.
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). CRRT MACHINE WAS ALARMING: MALFUNCTION, MEMORY ERROR. AN ERROR CODE 6 ALSO OCCURRED DUE TO A SET VALUE INCONGRUENCE BETWEEN THE PROTECTIVE AND CONTROL ON THE CRRT. BLOOD WAS GIVEN BACK TO THE PATIENT. THE PATIENT WAS RESTARTED ON A NEW CRRT MACHINE. DIALYSIS UNIT WAS CALLED. WE ARE AWAITING A RESPONSE FROM THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVVH, BLOOD PUMP | DIALYSIS EQUIPMENT (DESCRIBE BELOW) | KDI | GAMBRO RENAL PRODUCTS, INC. | PRISMAFLEX | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |