FDA Adverse Event
Malfunction
Summary report: N
TERUMO CENTRIFUGAL SYSTEM
MDR report key: 1012794
·
Received March 12, 2008
Report
- Report Number
- 1828100-2008-00178
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 8, 2008
- Report Date
- March 12, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP
- Product Code
- KFM
- PMA / PMN Number
- K902198
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
DURING SERVICE OF THE DEVICE, THE CENTRIFUGAL PUMP BATTERY MODULE WOULD NOT OPERATE A CENTRIFUGAL PUMP FOR MORE THAN 60 SECONDS BEFORE INDICATING COMPLETE BATTERY DISCHARGE. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO CENTRIFUGAL SYSTEM | CENTRIFUGAL PUMP BATTERY MODULE | KFM | TERUMO CARDIOVASCULAR SYSTEMS CORP | 9490 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |