FDA Adverse Event
Malfunction
Summary report: N
IMPELLA
MDR report key: 3904336
·
Received June 26, 2014
Report
- Report Number
- 3904336
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Date of Event
- January 30, 2014
- Report Date
- June 26, 2014
- Manufacturer
- ABIOMED, INC.
- Product Code
- KFM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
Narratives
Description of Event or Problem · 1
ONCE DEVICE WAS STARTED IT WAS FOUND TO NOT PERFORM AT THE FULL 2.5 LPM; AFTER TROUBLESHOOTING AND SPEAKING WITH THE REP IT WAS DETERMINED TO HAVE A CLOT IN THE DEVICE OR THAT THE PATIENT WAS HYPOVOLEMIC. THE PATIENT WAS GIVEN A FLUID BOLUS. THIS DID NOT CORRECT THE ISSUE SO THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW ONE PLACED, WHICH WORKED CORRECTLY. THE DEVICE WAS INSPECTED AND THE CLOT WAS FOUND IN THE DEVICE. THE REP STATED THAT THE CLOT MOST LIKELY WAS FROM A CLOT IN THE SHEATH OR AN UNKNOWN LV THROMBUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373966 | IMPELLA | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | ABIOMED, INC. | LP2 | 77801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |