FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
MDR report key: 1832658
·
Received September 13, 2010
Report
- Report Number
- 6000001-2007-00669
- Event Type
- Malfunction
- Date Received
- September 13, 2010
- Date of Event
- December 20, 2006
- Report Date
- December 20, 2006
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 BEING INVESTIGATED UNDER CAPA (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, A BROKEN DOOR HANDLE WAS 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 6201 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE (SG) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |