FDA Adverse Event
Malfunction
Summary report: N
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
MDR report key: 9415733
·
Received December 5, 2019
Report
- Report Number
- 8010762-2019-00384
- Event Type
- Malfunction
- Date Received
- December 5, 2019
- Report Date
- December 5, 2019
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ROTAFLOW EMERGENCY DRIVE WAS INVESTIGATED FROM THE GETINGE SERVICE TECHNICIAN WITH THE SUMMARY REPORT# (B)(4) ON THE (B)(6) 2019: DURING INSPECTION IT WAS FOUND THAT THE HANDLE (TO TURN THE EMERGENCY DRIVE WAS BROKEN. THEREFORE THE CRANK HANDLE WAS REPLACED AND TESTED AS PER SERVICE MANUAL. ALL TESTS PASSED. MOST PROBABLE ROOT CAUSE: IN PROPER AND ROUGH HANDLING. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.
Description of Event or Problem · 1
(B)(4). DURING INSPECTION A BROKEN RFE CRANK HANDLE WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1210495 | ROTAFLOW CENTRIFUGAL PUMP SYSTEM | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | 701022162 - ROTAFLOW EMERGENCY DRIVE | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |