FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2871923
·
Received December 13, 2012
Report
- Report Number
- 1416980-2012-07207
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- November 19, 2012
- Report Date
- November 20, 2012
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION: THE CUSTOMER REPORTED BROKEN CABLE WAS CONFIRMED AND REPRODUCED DURING EVALUATION BY TECHNICAL SERVICES. THE CAUSE WAS DETERMINED TO BE A BROKEN POWER CORD AND THE POWER CORD WAS REPLACED TO RESOLVE THE PROBLEM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH A BROKEN CABLE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF 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 |
|---|---|---|---|---|---|---|---|
| 1 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |