FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3070890
·
Received April 22, 2013
Report
- Report Number
- 1416980-2013-09995
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 2, 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 CUSTOMER REPORTED CONDITION ALARM F-6 WAS CONFIRMED DURING DEVICE EVALUATION. THE CAUSE WAS DUE TO DEFECTIVE MAIN BATTERIES. THE MAIN BATTERY WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLOGARD INFUSION PUMP ALARMED FAILURE CODE 6. IT IS UNKNOWN IN WHICH CARE AREA OR THE PROCESS STEP THAT THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171593 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |