FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
MDR report key: 1130043
·
Received August 19, 2008
Report
- Report Number
- 6000001-2008-00479
- Event Type
- Malfunction
- Date Received
- August 19, 2008
- Date of Event
- July 3, 2008
- Report Date
- July 3, 2008
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- PMA / PMN Number
- K915522
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A CONSTANT OCCLUSION ALARM DURING A PATIENT INFUSION. IT IS UNKNOWN IF THERE WERE ANY REPORTS OF INJURY OR MEDICAL INTERVENTION. BAXTER HAS MADE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION FROM THE CUSTOMER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6201 VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE (SG) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |