FDA Adverse Event
Malfunction
Summary report: N
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
MDR report key: 1033508
·
Received April 23, 2008
Report
- Report Number
- 6000001-2008-00270
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 31, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- 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
A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED "DOESN'T WORK, FREQUENTLY SOUNDS" DURING PT INFUSION. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFO, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFO. ACCORDING TO THE FACILITY REPRESENTATIVE, NO PT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. IN ADDITION, THE FACILITY REPRESENTATIVE REPORTED "UNIT MADE NOISE WHILE CONNECTED TO PT. NURSE REMOVED THE UNIT FROM PT FOR THAT REASON WAS NOT AFFECTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLO-GARD 6201 VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |