FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
MDR report key: 1130024
·
Received August 19, 2008
Report
- Report Number
- 6000001-2008-00478
- Event Type
- Malfunction
- Date Received
- August 19, 2008
- Date of Event
- July 23, 2008
- Report Date
- July 24, 2008
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- PMA / PMN Number
- K915523
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IN 2008, THE CUSTOMER REPORTED THAT 1 DEVICE, PRODUCT CODE 2M8064, LOT NUMBER 505717FB IS NOT MAKING NOISE WHEN AN ALARM IS SUPPOSED TO BE SOUNDING. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS COMPLAINT OR ANY PATIENT INVOLVEMENT WHEN THE COMPLAINT CONDITION WAS DETECTED. AT THIS TIME A RGA (RETURN GOODS AUTHORIZATION) WAS ISSUED TO BRING THE DEVICE TO CTS (CANADA TECHNICAL SERVICES) FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6301 VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE (SG) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |