FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2974302
·
Received February 22, 2013
Report
- Report Number
- 1416980-2013-04469
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- January 1, 2013
- Report Date
- January 28, 2013
- 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). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH "FSR'S DAMAGED" WAS CONFIRMED DURING EVALUATION.. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE DAMAGED FORCE-SENSING RESISTORS. THE FORCE-SENSING RESISTORS WERE REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP EXPERIENCED " FSRS DAMAGED" (FORCE SENSING RESISTORS). IT IS UNKNOWN WHEN, OR IN WHICH CARE AREA, THIS EVENT OCCURRED. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77729 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |