FDA Adverse Event
Malfunction
Summary report: N
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
MDR report key: 6022362
·
Received October 12, 2016
Report
- Report Number
- 8010762-2016-00623
- Event Type
- Malfunction
- Date Received
- October 12, 2016
- Date of Event
- September 27, 2016
- Report Date
- September 28, 2016
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FIELD SAFETY TECHNICIAN WAS SENT FOR INVESTIGATION. THE DRIVE ASSEMBLY: NO PROBLEM FOUND. THE TECHNICIAN STATED (ACCORDING TO SERVICE ORDER 40199378/310566753) THAT THE UNIT WAS TESTED BY THE CUSTOMER WITHOUT CONNECTING THE ROTAFLOW DRIVE - INCORRECT TESTING. THUS THE FAILURE COULD NOT BE CONFIRMED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ERROR 11 HEAD OCCURED DURING TESTING. NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675808 | ROTAFLOW CENTRIFUGAL PUMP SYSTEM | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY AG | ROTAFLOW DRIVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |