FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2982453
·
Received February 28, 2013
Report
- Report Number
- 1416980-2013-04891
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 1, 2012
- Report Date
- December 17, 2012
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915523
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION WAS CONFIRMED, DURING ON-SITE SAMPLE SERVICE, AS AN F-94 ALARM. THE ROOT CAUSE WAS DETERMINED TO BE DEFECTIVE BATTERIES. THE BATTERIES WERE REPLACED TO CORRECT THE REPORTED CONDITION.
Description of Event or Problem · 1
IT WAS REPORTED TO BAXTER (B)(4) THAT A FLOGARD INFUSION PUMP WOULD "ONLY TURN ON 1 CHANNEL". IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, NOR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86863 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |