FDA Adverse Event
Death
Summary report: N
NA
MDR report key: 257696
·
Received January 5, 2000
Report
- Report Number
- 1218444-1999-00021
- Event Type
- Death
- Date Received
- January 5, 2000
- Manufacturer
- NA
- Product Code
- DSQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
NA
Description of Event or Problem · 1
THE VE LEFT VENTRICULAR ASSIST DEVICE WAS IMPLANTED ON 11/17/1999. DURING THE 14 POST-OPERATIVE DAYS THE PT HAD PROBLEMS WITH LOW FLOWS SEVERAL TIMES WITH FLOWS OF 1 TO 2 LITERS. A THORACOTOMY WAS PERFORMED AND THE PUMP WAS MANIPULATED BY HAND TO IMPROVE PUMP FILLING. THIS WAS SUCCESSFUL FOR A FEW DAYS WITH FILLING OF THE PUMP TO ALMOST NORMAL. ON 12/04/1999, THE PT HAD LOW FLOW PROBLEMS AGAIN. A SECOND THORACOTOMY WAS PERFORMED AND SOME PERFORATIONS AT THE INFLOW SITE WERE FOUND. THE APICAL SEWING RING WAS EXCHANGED AND A NEW ONE WAS INSERTED; HOWEVER, THE PT DID NOT RECOVER AND DIED THE SAME DAY, 12/04/1999.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | NA | DSQ | NA | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Death |