FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
MDR report key: 1231536
·
Received November 18, 2008
Report
- Report Number
- 6000001-2007-05560
- Event Type
- Malfunction
- Date Received
- November 18, 2008
- Date of Event
- March 1, 2007
- Report Date
- March 15, 2007
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPORTS A DEVICE WITH A BROKEN DOOR LATCH ON CHANNEL 1, FOUND DURING BIOMED TESTING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6301 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |