BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1051948 · Received May 22, 2008

    Report

    Report Number
    6000001-2008-00334
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D FOR EVALUATION, HOWEVER, EVALUATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED "NOT WORKING" ON A FLOGARD PUMP DURING USE, WITH NO PT INVOLVED. 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 HAS BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1