FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 2980226
·
Received February 27, 2013
Report
- Report Number
- 1416980-2013-04772
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 7, 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). CORRECTION ON (CATALOG NUMBER), (510K NUMBER) AND (EVALUATION CODE SET).
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED PROBLEM OF A FLOGARD INFUSION PUMP WITH A DAMAGED DOOR WAS CONFIRMED. SERVICE DISCOVERED BY VISUAL INSPECTION THAT THE DOOR WAS CRACKED. SERVICE REPLACED THE DOOR ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN ASSEMBLY TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT PRESENTED "DAMAGED DOOR". IT IS UNKNOWN IF THIS EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85460 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |