FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2983559
·
Received February 28, 2013
Report
- Report Number
- 1416980-2013-04962
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Report Date
- February 12, 2013
- 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). THE EXACT DATE THE EVENT OCCURED IS UNKNOWN. THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING PRODUCT EVALUATION BY A SERVICE TECHNICIAN A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE AN F-38 ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88234 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |