FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
MDR report key: 1024008
·
Received April 4, 2008
Report
- Report Number
- 6000001-2007-03819
- Event Type
- Malfunction
- Date Received
- April 4, 2008
- Date of Event
- December 1, 2006
- Report Date
- December 27, 2006
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY:THE PUMP WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN. THE REPORTED CONDITION WAS CONFIRMED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, CRACKED DOOR ASSEMBLIES #1 AND #2 WERE FOUND. ACCORDING TO THE FACILITY REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6301 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE (SG) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |