FDA Adverse Event
Malfunction
Summary report: N
BIO-PUMP
MDR report key: 204465
·
Received December 30, 1998
Report
- Report Number
- 2124837-1998-00021
- Event Type
- Malfunction
- Date Received
- December 30, 1998
- Report Date
- December 30, 1998
- Manufacturer
- MEDTRONIC BIO-MEDICUS, INC.
- Product Code
- KFM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MEDTRONIC BIO-MEDICUS, INC RECEIVED A REPORT THAT DURING USE AT HOSP, THE BIO-PUMP CRACKED, ADN THE BACK PLATE AND HOUSING SEPARATED. THE PT WAS NOT REPORTED TO BE AFFECTED BY THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-PUMP | EXTRACORPOREAL CENTRIFUGAL BLOOD PUMP | KFM | MEDTRONIC BIO-MEDICUS, INC. | BP-80 | 9601000117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |