FDA Adverse Event
Malfunction
Summary report: N
AVANTA FLUID MANAGEMENT SYSTEM
MDR report key: 2434307
·
Received January 30, 2012
Report
- Report Number
- 2434307
- Event Type
- Malfunction
- Date Received
- January 30, 2012
- Report Date
- January 30, 2012
- Manufacturer
- MEDRAD, INC.
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
UPON REFILLING THE FLUID MANAGEMENT SYSTEM WITH MORE CONTRAST, THE AIR VENT PORT OF THE MPAT CONTRAST TUBING SPIKE POPPED OFF WHEN PULLING THE SPIKE OUT OF THE EXISTING EMPTY BOTTLE OF CONTRAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVANTA FLUID MANAGEMENT SYSTEM | TUBING, CONTRAST INJECTION | DXT | MEDRAD, INC. | AVA 500 MPAT | 113401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |