BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE

    MDR report key: 3732911 · Received February 10, 2014

    Report

    Report Number
    3732911
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 10, 2014
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SMITHS MEDICAL HOTLINE DISPOSABLE HAS BEEN LEAKING AT THE JUNCTION OF THE REGULAR IV TUBING WITH THE HEATING CORE WHERE THERE IS A NEEDLE PIERCING ACCESS POINT. THE PRODUCT IS HOTLINE FLUID WARMING SET BY SMITHS MEDICAL. THIS HAS OCCURRED AT LEAST 4 TIMES AT OUR FACILITY. THE USED DISPOSABLES ARE SEQUESTERED FROM THE FOLLOWING LOT NUMBERS:LOT # 2602458; EXP - 2017-11 LOT #2602458; EXP - 2017-11 LOT #2602458; EXP - 2017-11 LOT #2607387; EXP - 2017-11 ON TWO OF THESE OCCASIONS BLOOD WAS INFUSING, WHICH BOTH DELAYED A PATIENT WHO NEEDED BLOOD IN RECEIVING IT AND WASTED PART OF A UNIT OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87780 LEVEL 1 HOTLINE WARMER, THERMAL, INFUSION, BLOOD LGZ SMITHS MEDICAL ASD, INC. * #2602458 & #2607387

    Patients

    Seq Age Sex Outcome Treatment
    1 *