FDA Adverse Event
Death
Summary report: N
BIOPUMP PLUS
MDR report key: 10586088
·
Received September 25, 2020
Report
- Report Number
- 2184009-2020-00061
- Event Type
- Death
- Date Received
- September 25, 2020
- Date of Event
- September 16, 2020
- Report Date
- September 25, 2020
- Manufacturer
- PERFUSION SYSTEMS
- Product Code
- DWE
- PMA / PMN Number
- K973011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE BPX-80 ADULT BIO-PUMP® PLUS CENTRIFUGAL PUMP LEAKED, AND THE PATIENT HAD A LARGE BLOOD LOSS. THE PATIENT WAS ON ECMO ON (B)(6) 2020 AT 4 PM. AT 10PM THE PATIENT HAD BP DROPPED AND CPR WAS PERFORMED. THE NURSE THEN FOUND THE BIO-PUMP WAS LEAKING, SO THEY CALLED THE PERFUSIONIST. THE PERFUSIONIST TRIED TO CHANGE BIO-PUMP. THE PATIENT LOST A LOT OF BLOOD AND EXPIRED AT 10.30 PM. THE CUSTOMER THOUGHT THE BIO-PUMP MAY BE ONE OF THE CAUSES OF PATIENT DEATH. PATIENT MEDICAL HISTORY: ALLERGY, LUNG PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1050315 | BIOPUMP PLUS | TUBING, PUMP, CARDIOPULMONARY BYPASS | DWE | PERFUSION SYSTEMS | BPX-80 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Death| R |