BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4130432 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33926
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 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. A VISUAL INSPECTION, ALARM LOG REVIEW AND A POWER ON SELF-TEST WERE PERFORMED. DURING THE ALARM LOG REVIEW AND THE POWER ON SELF-TEST, AN F-38 ALARM WAS IDENTIFIED. THE CAUSE OF THE ALARM WAS OUT OF SPECIFICATION FORCE SENSING RESISTORS (FSRS). THE FSRS WERE REPLACED TO FIX THE REPORTED CONDITION. 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

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN F-38 ALARM (MALFUNCTION IN TUBE MISLOADING DETECTION CIRCUITRY). THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608914 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1