FDA Adverse Event
Death
Summary report: N
CONSTAVAC
MDR report key: 87228
·
Received April 21, 1997
Report
- Report Number
- 87228
- Event Type
- Death
- Date Received
- April 21, 1997
- Date of Event
- August 22, 1996
- Report Date
- April 15, 1997
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- CAC
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT RECEIVED CELL SAVER INFUSION FOR LOW BLOOD PRESSURE 80/40 IN OR S/P BILATERAL TOTAL KNEE REPLACEMENT. TWENTY MINUTES POST-OPERATIVELY, PT ARRESTED. AUTOPSY REPORT SHOWED MICROSCOPIC FAT BONE MARROW CAUSED PULMONARY EMBOLI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTAVAC | BLOOD REINFUSER | CAC | STRYKER INSTRUMENTS | 215-28 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death |