BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1052871 · Received May 27, 2008

    Report

    Report Number
    6000001-2008-00343
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 13, 2008
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVAL. WHEN THE PUMP IS RECEIVED FOR EVAL, 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 "INFUSES TOO FAST" ON A FLOGARD PUMP. INFO WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PT INFUSION. 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