FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 4152999
·
Received October 8, 2014
Report
- Report Number
- 1416980-2014-35044
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 15, 2014
- Report Date
- September 15, 2014
- 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). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT EVALUATED AS PART OF PREVENTIVE MAINTENANCE. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. DURING VISUAL INSPECTION A DAMAGED LATCH ROLLER WAS IDENTIFIED; THE CAUSE WAS UNDETERMINED. TO CORRECT THE CONDITION, THE LATCH ROLLER WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLOGARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED LATCH ROLLER. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631496 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |