FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3011192
·
Received March 19, 2013
Report
- Report Number
- 1416980-2013-06582
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Date of Event
- February 22, 2013
- Report Date
- February 22, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM OF A FLOGARD INFUSION PUMP WITH AN F94 ALARM WAS CONFIRMED. SERVICE DETERMINED THAT THE CAUSE WAS DUE TO DAMAGED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO RESOLVE THE ISSUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
Description of Event or Problem · 1
THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT PRESENTED AN "F94 ALARM". IT IS UNKNOWN IF THIS EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114515 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |