FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2993239
·
Received March 7, 2013
Report
- Report Number
- 1416980-2013-05527
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- November 9, 2012
- Report Date
- February 14, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915523
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF "IS NOT WORKING (ALARM NOT SPECIFIED)" WAS CONFIRMED DURING DEVICE EVALUATION AS AN F-63 ALARM. THE ROOT CAUSE WAS NOT ABLE TO BE IDENTIFIED. THIS DEVICE IS A STAY-IN UNIT, THEREFORE, NO REPAIRS HAVE BEEN MADE.
Description of Event or Problem · 1
IT WAS REPORTED TO BAXTER ARGENTINA THAT A FLOGARD INFUSION PUMP "IS NOT WORKING (ALARM NOT SPECIFIED)." IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97991 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |