BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPID INFUSER RI-2, 120V, 1000ML/MIN

    MDR report key: 20300082 · Received September 25, 2024

    Report

    Report Number
    20300082
    Event Type
    Death
    Date Received
    September 25, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 11, 2024
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE BELMONT OVERHEATED DURING USE AND WAS NONFUNCTIONAL; WOULD ONLY TRANSFUSE AT 50ML/MIN, FOR ONE MINUTE, AND SHUT DOWN GIVING AND OVERHEATING ERROR. PATIENT UNDERWENT PLANNED RIGHT RATS LOWER LOBECTOMY WITH MEDIASTINAL LYMPH NODE DISSECTION AND INTERCOSTAL BLOCKS IN THE MORNING OF [REDACTED]. HE EXTUBATED AND WENT TO THE RECOVERY ROOM FOR ABOUT TWO HOURS. AT THAT TIME THE PATIENT RAPIDLY DUMPED 900CC OF BLOOD INTO HIS CHEST TUBES THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM, INTUBATED WITH A DOUBLE LUMEN TUBE, PREPPED AND DRAPED. HE UNDERWENT AN ANTEROLATERAL MUSCLE SPARING THORACOTOMY. POST-OP HEMORRHAGE RESULTING IN HEMORRHAGIC SHOCK AND EXPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292490 RAPID INFUSER RI-2, 120V, 1000ML/MIN WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT LLC 903-00037

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Death