BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER FLOGARD 6201

    MDR report key: 3300235 · Received August 16, 2013

    Report

    Report Number
    MW5031517
    Event Type
    Malfunction
    Date Received
    August 16, 2013
    Date of Event
    June 27, 2013
    Report Date
    August 15, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVING IV FLUIDS OF D5NS WITH IV PUMP IN PLACE. PATIENT HAD HYPOGLYCEMIC EPISODE WITH BLOOD SUGAR AT 28 AND 31 AROUND 0600. AT APPROXIMATELY 0630, IT WAS NOTED THAT THE IV PUMP WAS NOT FUNCTIONING. BASED ON THE FLUIDS LEFT IN THE BAG, APPROX 600-700CC OF FLUID INFUSED AND PUMP MALFUNCTIONED AROUND 0330-0430. PUMP WAS REMOVED BY NS AND SEQUESTERED BY THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395577 BAXTER FLOGARD 6201 VOLUMETRIC INFUSION PUMP FRN BAXTER HEALTHCARE FLO-GARD 6201

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR