BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3191212 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16466
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    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 DEVICE WAS SERVICED AT THE CUSTOMER SITE. THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED CONDITION OF AN OCCLUSION ALARM WAS CONFIRMED AS AN F-2 ALARM. THE CAUSE OF THE REPORTED CONDITION WAS DUE TO A DAMAGED LATCH ROLLER. IN ORDER TO RESOLVE THE ISSUE THE LATCH ROLLER WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD EXPERIENCED AN OCCLUSION ALARM. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289772 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1