BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3130719 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13457
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 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 FLOGARD INFUSION PUMP WAS SERVICED ON-SITE. THE "DOOR OPEN" ALARM WAS CONFIRMED DURING A REVIEW OF THE ALARM LOG. UPON VISUAL INSPECTION THE DOOR LATCH WAS FOUND TO BE BROKEN. THE DOOR LATCH WAS REPLACED TO FIX THE REPORTED CONDITION. THE PUMP PASSED ALL TESTS AND WAS RETURNED TO THE CUSTOMER IN WORKING ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLOGARD INFUSION PUMP ALARMED "DOOR OPEN". THE PROCESS STEP THAT THIS MALFUNCTION WAS IDENTIFIED IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230934 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1