FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3071233
·
Received April 22, 2013
Report
- Report Number
- 1416980-2013-10009
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 1, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED DURING DEVICE EVALUATION. THE RIGHT FORCE SENSING RESISTOR (FSR) WAS FOUND TO BE DAMAGED. THE FSR WAS REPLACED TO RESOLVE THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT ALARMED FAILURE CODE 38. IT IS UNKNOWN IN WHICH CARE AREA OR THE PROCESS STEP THAT THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172557 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |