FDA Adverse Event
Malfunction
Summary report: N
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
MDR report key: 4285674
·
Received December 1, 2014
Report
- Report Number
- 8010762-2014-00533
- Event Type
- Malfunction
- Date Received
- December 1, 2014
- Date of Event
- October 10, 2011
- Report Date
- October 25, 2011
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CONTROL BOARD WAS REPLACED IN THE UNIT BY THE MAQUET SALES AND SERVICE UNIT TECHNICIAN. TESTING WAS PERFORMED AFTER THE CONTROL BOARD WAS REPLACED AND THE TEST RESULTS WERE ACCEPTABLE. REFERENCE: (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, ROTAFLOW (B)(4) ZH-PLUG WITH SERIAL NUMBER (B)(4) AT (B)(6) HOSPITAL, GAVE A "RUNAWAY" ERROR MESSAGE. THE COMPLAINT INFORMATION DID NOT NOTATE IF A PATIENT WAS INVOLVED. REFERENCE: COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773750 | ROTAFLOW CENTRIFUGAL PUMP SYSTEM | PUMP, BLOOD, CARDIOPULMONARY BYPASS | KFM | MAQUET CARDIOPULMONARY AG | MCP00706291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |