FDA Adverse Event
Malfunction
Summary report: N
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
MDR report key: 4931870
·
Received July 22, 2015
Report
- Report Number
- 8010762-2015-00607
- Event Type
- Malfunction
- Date Received
- July 22, 2015
- Date of Event
- May 12, 2014
- Report Date
- May 13, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND HENCE NO EVALUATION WAS PERFORMED. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2014 THE (B)(6) HOSPITAL IN (B)(6) IT WAS REPORTED THAT DURING A V-A ECMO PROCEDURE ALL THE KEYS AND POTENTIOMETER ON THE ROTAFLOW CONSOLE SERIAL NUMBER (B)(4) STOPPED WORKING. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474550 | ROTAFLOW CENTRIFUGAL PUMP SYSTEM | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY AG | 70104,6405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |