BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3981883 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25398
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FLOGARD INFUSION PUMP WAS SERVICED ON-SITE. A VISUAL INSPECTION AND AN ALARM LOG REVIEW WERE PERFORMED. DURING SERVICE IT WAS IDENTIFIED THAT THE AC ICON WOULD NOT TURN ON WHEN THE PUMP WAS CONNECTED TO ELECTRIC CURRENT. THIS MALFUNCTION WAS CAUSED BY A BLOWN MAIN FUSE. THE MAIN FUSE WAS REPLACED TO FIX THE REPORTED CONDITION. THE PUMP PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER IN WORKING ORDER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP'S AC ICON WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458372 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1