BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET

    MDR report key: 14753378 · Received June 21, 2022

    Report

    Report Number
    14753378
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    UDI-DI
    00896128002022
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ¿TONIGHT, WE WERE DOING MTP ON A PATIENT. THE BELMONT WAS RUNNING SMOOTHLY UNTIL WE MADE IT TO THE 3RD BAG OF BLOOD PRODUCT AND RN#2 NOTICED THAT IT WAS LEAKING FROM INSIDE THE MACHINE. RN#1 STOPPED IT AND TOOK IT OUT BUT COULD NOT FIND WHERE IT WAS COMING FROM AT THE TIME. RN#1 CLEANED IT OFF AND STARTED IT AGAIN AND IT STARTED LEAKING WORSE. NOT SURE IF THIS HAS HAPPENED TO ANYONE ELSE BUT THE TUBING CAME STRAIGHT OUT OF THE PACKAGING AND WENT RIGHT INTO THE MACHINE. RN#1 DID NOT HAVE ANY ISSUES WHEN PUTTING IT IN THERE AND NOTHING HIT IT EITHER." BELMONT RI-2 INVOLVED. MACHINE OUT OF SERVICE, WORK ORDER PLACED FOR CLINICAL ENGINEERING TO REVIEW MACHINE. BELMONT REP MADE AWARE AND OPENED INVESTIGATION. BELMONT TUBING SEQUESTERED AND BEING HELD FOR SHIPPING TO BELMONT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162121 3-SPIKE DISPOSABLE SET WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT CORPORATION 903-00006P 20220408 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA Female