FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2904011
·
Received January 9, 2013
Report
- Report Number
- 1416980-2013-00613
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 18, 2012
- Report Date
- December 18, 2012
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT. THE CAUSE WAS DETERMINED TO BE A DEFECTIVE BATTERY. TO CORRECT THE CONDITION, THE BATTERY WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLOGARD VOLUMETRIC INFUSION PUMP WAS FOUND TO HAVE A FAILURE CODE F49. THIS WAS NOT REPORTED BY THE CUSTOMER. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10620 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |