BEUDAMED
    FDA Adverse Event Death Summary report: N

    BELMONT INSTRUMENT CORPS

    MDR report key: 8621006 · Received May 9, 2019

    Report

    Report Number
    8621006
    Event Type
    Death
    Date Received
    May 9, 2019
    Date of Event
    April 27, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BELMONT
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BELMONT RAPID INFUSER FAILED DURING CRITICAL NEED ON A PT IN THE ICU, IT WAS REPORTED THAT DURING USE, THE ROLLER DISENGAGED FROM THE RIVER SHAFT CAUSING UNIT FAILURE. PT EXPIRED. UNIT WAS SENT TO BIOMEDICAL ENGINEERING AND UPON VISUAL INSPECTION, IT WAS FOUND THAT THE UNIT'S ROLLER HEAD RETAINING SCREW WAS MISSING. UNIT WAS ISOLATED AND WILL BE SENT TO THE MFR FOR IN DEPTH INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387400 BELMONT INSTRUMENT CORPS RAPID INFUSER FRN BELMONT FMS200

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death