BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1565043 · Received December 28, 2009

    Report

    Report Number
    6000001-2009-01371
    Event Type
    Malfunction
    Date Received
    December 28, 2009
    Date of Event
    December 1, 2009
    Report Date
    December 1, 2009
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 49, WHICH INTERRUPTED A PATIENT INFUSION, CANNOT BE CONFIRMED AS THIS FACILITY IS NOT SENDING THE PUMP TO BAXTER FOR DEVICE EVALUATION OR REPAIR. THEREFORE, NO ASSIGNABLE CAUSE CAN BE PROVIDED AND NO REPAIRS WILL BE MADE.SHOULD THIS PUMP BE RECEIVED BY BAXTER FOR EVALUATION, OR IF ANY ADDITIONAL INFORMATION ABOUT THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED A FLO-GARD INFUSION PUMP WHICH ALARMED FAILURE CODE 49 AND INTERRUPTED A PATIENT INFUSION OF GAMMAGARD SD. THE PUMP WAS INFUSING 600ML OF GAMMAGARD SD AT 125ML/HR WHEN THE (B) (6) FEMALE PATIENT UNPLUGGED THE DEVICE TO USE THE RESTROOM. UPON UNPLUGGING THE DEVICE, THE PUMP ALARMED FAILURE CODE 49 AND STOPPED INFUSING. THE NURSE IMMEDIATELY BEGAN GRAVITY INFUSING THE GAMMAGARD SD AND THE PATIENT CONTINUED TO RECEIVE THERAPY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR