FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD
MDR report key: 3052640
·
Received April 11, 2013
Report
- Report Number
- 1416980-2013-09030
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 22, 2013
- 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 CUSTOMER REPORTED PROBLEM OF A DAMAGED DOOR WAS CONFIRMED IN THE SAMPLE EVALUATION. UPON VISUAL INSPECTION OF THE DEVICE DOOR ASSEMBLY WAS FOUND TO BE BROKEN/CRACKED. THE PUMP HEAD DOOR ASSEMBLY WAS REPLACED TO RESOLVE THE REPORTED PROBLEM.
Description of Event or Problem · 1
IT WAS REPORTED TO BAXTER THAT A FLOGARD INFUSION PUMP HAD A DAMAGED DOOR. 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 |
|---|---|---|---|---|---|---|---|
| 156797 | FLO-GARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |