BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3230571 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18716
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 11, 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 FUNCTIONALLY TESTED. THE REPORTED CONDITION, "OUT OF SERVICE", WAS MORE SPECIFICALLY IDENTIFIED AS AN AIR IN LINE ALARM. THE REPORTED CONDITION WAS DUE TO THE AIR SENSOR BEING OUT OF CALIBRATION. TO CORRECT THE ISSUE THE AIR SENSOR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP WAS "OUT OF SERVICE". THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329896 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1