FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
MDR report key: 1813486
·
Received August 24, 2010
Report
- Report Number
- 6000001-2010-02727
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- July 13, 2010
- Report Date
- July 13, 2010
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY:THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A FALSE UPSTREAM OCCLUSION ALARM WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY THE PUMP'S DOOR ASSEMBLY BEING BROKEN AT THE UPPER AND LOWER HINGE STOPS. THE DOOR ASSEMBLY WAS REPLACED 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 UPSTREAM OCCLUSION ALARM. THIS CONDITION WAS DISCOVERED DURING PROGRAMMING/SET-UP IN THE FACILITY'S PEDIATRICS CARE AREA. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION 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 |