FDA Adverse Event
Death
Summary report: N
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER
MDR report key: 3692477
·
Received March 5, 2014
Report
- Report Number
- 3008355164-2014-00046
- Event Type
- Death
- Date Received
- March 5, 2014
- Report Date
- February 17, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DWF
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ECLS PROCEDURE THE VENOUS LINE PRESSURE MOVED FROM -70 TO -10. THE ISSUE WAS SUPPOSED TO BE WITH THE AVALON CATHETER. THE PRODUCT WAS DISCARDED BY THE USER FACILITY. PT SUFFERED OF H1N1 AND EVENTUALLY DID EXPIRE. (B)(4). MFR REF #8010762-2014-00111.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132986 | AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER | CATHETER, INTRAVASCULAR, GENERAL-PURPOSE | DWF | MAQUET CARDIOPULMONARY AG | 10031 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |