FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3100605
·
Received May 8, 2013
Report
- Report Number
- 1416980-2013-11744
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Report Date
- April 13, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. AFTER REVIEW OF THE ALARM LOG, THE REPORTED CONDITION OF A CONSTANT ALARM WAS CONFIRMED AS AN F-94 ALARM. THE CAUSE OF THE F-94 ALARM WAS DETERMINED TO BE A BLOWN FUSE. IN ORDER TO CORRECT THE CONDITION, THE FUSE WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD A CONSTANT 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 |
|---|---|---|---|---|---|---|---|
| 201932 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |