BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 12029068 · Received June 18, 2021

    Report

    Report Number
    1219702-2021-00086
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3-SPIKE DISPOSABLE SET INVOLVED IN THE INCIDENT WAS DISCARDED AT THE HOSPITAL AND WAS THEREFORE NOT AVAILABLE FOR INVESTIGATION. THE USER FACILITY REPORTED THAT THE PACKAGING HAD ALREADY BEEN DISCARDED, BUT WAS ABLE TO PROVIDE THE LOT NUMBER LIKELY INVOLVED. WITHOUT THE ABILITY TO INVESTIGATE THE SET A ROOT CAUSE CANNOT BE ESTABLISHED. THE MANUFACTURING BATCH RECORDS FOR THIS LOT WERE REVIEWED AND NO RELATED ANOMALIES WERE IDENTIFIED. ALL 3-SPIKE DISPOSABLE SETS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE FROM BELMONT MEDICAL TECHNOLOGIES. A REVIEW OF PAST COMPLAINTS INDICATES THAT THIS WAS AN ISOLATED INCIDENT; THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE. IT WAS REPORTED THAT THE USERS WERE ABLE TO PROCEED WITH THE CASE AND TRANSFUSE BLOOD QUICKLY; THERE WAS NO HARM TO THE PATIENT. BELMONT WILL CONTINUE TO MONITOR AND TREND SIMILAR REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE NURSE HAD DIFFICULTY INSTALLING THE UPPER PIECE OF THE 3-SPIKE DISPOSABLE SET INTO THE RAPID INFUSER DUE TO TIGHT FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920879 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET 2019-04 01 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1