BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4142429 · Received October 5, 2014

    Report

    Report Number
    1416980-2014-34551
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 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 BY A FIELD SERVICE TECHNICIAN AS PART OF PREVENTATIVE MAINTENANCE. THIS IS AN ANCILLARY SERVICE EVENT. A VISUAL INSPECTION AND A POWER ON SELF-TEST WERE PERFORMED. DURING THE VISUAL INSPECTION IT WAS IDENTIFIED THAT THE DOOR WAS BROKEN. THE CAUSE OF THE DAMAGE IS UNKNOWN. THE PUMP HEAD DOOR ASSEMBLY, DOOR LATCH ASSEMBLY AND LATCH ROLLER WAS REPLACED; THE PUMP 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

    DURING ON-SITE SERVICE, THE BAXTER SERVICE TECHNICIAN FOUND THAT THE FLOGARD INFUSION PUMP HAD A BROKEN DOOR. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621986 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1