FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2974389
·
Received February 22, 2013
Report
- Report Number
- 1416980-2013-04479
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- November 12, 2012
- Report Date
- November 12, 2012
- 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). (B)(6). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE ROOT CAUSE OF THE DAMAGED FORCE SENSING RESISTORS (FSRS) WAS DETERMINED TO BE DUE TO USE OF ALCOHOL IN THE CHANNEL. TO CORRECT THE CONDITION, THE FSRS WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SERVICING, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE DAMAGED FORCE SENSING RESISTORS (FSRS). NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77792 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |