FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3202376
·
Received July 2, 2013
Report
- Report Number
- 1416980-2013-17025
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 7, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS SERVICED AT THE CUSTOMER SITE AND THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED CONDITION OF AN F-49 ALARM WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DUE TO DEFECTIVE MAIN BATTERIES. TO RESOLVE THE ISSUE THE BATTERIES WERE REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN F-49 ALARM. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301003 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |