FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
MDR report key: 1823552
·
Received September 2, 2010
Report
- Report Number
- 6000001-2010-02960
- Event Type
- Malfunction
- Date Received
- September 2, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 23, 2010
- 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). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A FALSE AIR IN LINE ALARM WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY FLUID BEING SPILLED ON THE AIR SENSOR. THE AIR SENSOR WAS CLEANED AND ITS FUNCTIONALITY WAS VERIFIED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WITH A FALSE AIR IN LINE ALARM. THIS CONDITION OCCURRED DURING PROGRAMMING/SET UP IN THE FACILITY'S EMERGENCY ROOM. THERE IS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6201 VOLUMETRIC INFUSION PUMP | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |