FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3153164
·
Received June 8, 2013
Report
- Report Number
- 1416980-2013-14610
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 15, 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). THE REPORTED CONDITION OF ALARM 38 WAS CONFIRMED DURING DEVICE EVALUATION. THE DEVICE WAS EVALUATED ON-SITE BY A FIELD SERVICE TECHNICIAN. DURING ON-SITE EVALUATION, VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE RIGHT FORCE SENSING RESISTOR (FSR). THE RIGHT FSR WAS REPLACED TO CORRECT THE REPORTED CONDITION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN FLOGARD INFUSION PUMP GENERATED A "38" ALARM. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256072 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |