BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3223608 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18182
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 19, 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 AND THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED CONDITION OF AN F-38 ALARM WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DUE TO A DEFECTIVE LEFT FORCE SENSING RESISTOR (FSR). TO CORRECT THE ISSUE THE LEFT FSR WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN F-38 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
    322584 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1