BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1030334 · Received April 16, 2008

    Report

    Report Number
    6000001-2008-00240
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED "OVERINFUSING" ON A FLOGARD PUMP FOUND AFTER USE. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFO, DETAILS WERE NOT AVAILABLE REGARDING ADD'L CONTACT INFO. ACCORDING TO THE FACILITY REP, NO PT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADD'L 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