FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2950984
·
Received February 8, 2013
Report
- Report Number
- 1416980-2013-03368
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- January 1, 2013
- Report Date
- January 16, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION: THE ASSIGNABLE CAUSE WAS IDENTIFIED AS A DEPLETED MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO RESOLVE THE ISSUE. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE. THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH A LOW BATTERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54565 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |