FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
MDR report key: 1000304
·
Received February 14, 2008
Report
- Report Number
- 6000001-2008-00048
- Event Type
- Malfunction
- Date Received
- February 14, 2008
- Date of Event
- December 24, 2007
- Report Date
- December 24, 2007
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6201 VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |