BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3972452 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-24942
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 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). (B)(6). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. VISUAL INSPECTION, FUNCTIONAL TESTING, AND A REVIEW OF THE ALARM LOG WERE PERFORMED. FUNCTIONAL TESTING AND THE REVIEW OF THE ALARM LOG REVEALED THAT THE DEVICE HAD PRESENTED THE OPEN DOOR ALARM. VISUAL INSPECTION IDENTIFIED THAT THE DEVICE WAS MISSING A DOOR MAGNET. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE THE MISSING DOOR MAGNET. TO CORRECT THE CONDITION, THE DOOR MAGNET WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP PRESENTED THE DOOR OPEN 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
    450072 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1