FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
MDR report key: 957573
·
Received September 1, 2004
Report
- Report Number
- 6000001-2004-01367
- Event Type
- Malfunction
- Date Received
- September 1, 2004
- Date of Event
- July 4, 2004
- Report Date
- July 14, 2004
- Manufacturer
- BAXTER HEALTHCARE PIE. LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6301 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PIE. LTD. | 6301 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |