FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2781515
·
Received October 10, 2012
Report
- Report Number
- 1416980-2012-02100
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 26, 2012
- Report Date
- September 26, 2012
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT. THE CAUSE WAS DETERMINED TO BE DAMAGE TO THE POWER CORD. TO CORRECT THE CONDITION, THE POWER CORD WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED POWER CORD. THIS WAS NOT REPORTED BY THE CUSTOMER. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. 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 |