FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
MDR report key: 1024132
·
Received April 5, 2008
Report
- Report Number
- 6000001-2007-05321
- Event Type
- Malfunction
- Date Received
- April 5, 2008
- Date of Event
- February 1, 2007
- Report Date
- February 1, 2007
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY REPRESENTATIVE REPORTED UNSPECIFIED PROBLEM. EVALUATION SUMMARY: A BAXTER SERVICE TECHNICIAN EVALUATED THE PUMP AND FOUND BROKEN DOOR ASSEMBLY. THE REPORTED CONDITION OF UNSPECIFIED PROBLEM CAUSED BY A BROKEN DOOR ASSEMBLY 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.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, BROKEN DOOR 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 |