FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3243912
·
Received July 23, 2013
Report
- Report Number
- 1416980-2013-19525
- Event Type
- Malfunction
- Date Received
- July 23, 2013
- Date of Event
- May 24, 2013
- Report Date
- June 28, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED BY BAXTER. A VISUAL INSPECTION AND FUNCTIONAL TESTING CONFIRMED THE CUSTOMER REPORTED PROBLEM AS THE F-38 ALARM. THE CAUSE OF THE F-38 ALARM WAS DETERMINED TO BE DAMAGED FORCE SENSING RESISTORS. IN ORDER TO CORRECT THE CONDITION, THE FORCE SENSING RESISTORS WERE REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD AN UNSPECIFIED MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342865 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |