FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 3072512
·
Received April 23, 2013
Report
- Report Number
- 1416980-2013-10053
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 6, 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). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP THAT DOES NOT FUNCTION WAS CONFIRMED BY BAXTER SERVICE PERSONNEL ONSITE AT THE CUSTOMER FACILITY. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE A DAMAGED CENTRAL PROCESSING UNIT BOARD. THE DEVICE WAS SWAPPED AND NO REPAIRS WERE MADE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLO-GARD INFUSION PUMP THAT DOES NOT FUNCTION. 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 |
|---|---|---|---|---|---|---|---|
| 174631 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |