FDA Adverse Event
Death
Summary report: N
BIOMEDICUS ONE PIECE FEMORAL VENOUS CANNULA
MDR report key: 2419737
·
Received January 18, 2012
Report
- Report Number
- 2184009-2012-00006
- Event Type
- Death
- Date Received
- January 18, 2012
- Date of Event
- August 19, 2011
- Report Date
- December 21, 2011
- Manufacturer
- MEDTRONIC PERFUSION SYSTEMS
- Product Code
- DWF
- PMA / PMN Number
- K924642
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 A PATIENT PASSED AWAY DURING AN EMERGENCY BYPASS PROCEDURE DUE TO THE ARTERIAL AND VENOUS CANNULAE HAVING BEEN INCORRECTLY REVERSED WHEN CONNECTED TO THE PERFUSION CIRCUIT. IT WAS REPORTED THAT THE PATIENT DEATH WAS DUE TO THE INCORRECT CANNULA CONNECTION/SET UP. IT WAS REPORTED THAT WHEN THE PHYSICIANS NOTED THE POOL OF BLOOD ON THE FLOOR IT WAS ALREADY TOO LATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMEDICUS ONE PIECE FEMORAL VENOUS CANNULA | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | MEDTRONIC PERFUSION SYSTEMS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |