BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2781494 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-02091
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE. "THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING THE INVESTIGATION OF (B)(4)." THE CAUSE WAS IDENTIFIED TO BE THE CONFIGURATION OPTION SETTINGS CHECKSUM NOT BEING EQUAL TO ZERO DUE TO A DEPLETED MAIN BATTERY. "TO CORRECT THIS CONDITION THE MAIN BATTERY WAS REPLACED AND ALL CONFIGURATION SETTINGS WERE RESET AS PER SERVICE MANUAL." IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED ONE OCCURRENCE OF A FAILURE CODE 94. THIS WAS NOT REPORTED BY THE CUSTOMER. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1