BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 11135516 · Received January 7, 2021

    Report

    Report Number
    1219702-2021-00003
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    January 7, 2021
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE SERIAL NUMBER OF THE RAPID INFUSER DEVICE NOR THE LOT NUMBER OF THE ASSOCIATED DISPOSABLE SET WERE PROVIDED. THE DISPOSABLE SET INVOLVED IN THE INCIDENT WAS DISCARDED AT THE HOSPITAL AND WAS THEREFORE NOT AVAILABLE FOR INVESTIGATION. THE USER FACILITY WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLE SET, HOWEVER THROUGH A REVIEW OF THE HOSPITAL'S ORDER HISTORY WE WERE ABLE TO DETERMINE THE THREE LOT NUMBERS THAT WERE RECENTLY SHIPPED AND THEREFORE POTENTIALLY INVOLVED. THE MANUFACTURING BATCH RECORDS FOR THESE LOTS WERE REVIEWED AND NO RELATED ANOMALIES WERE IDENTIFIED. ALL DISPOSABLE SETS ARE 100% LEAK TESTED AND 100% VISUALLY INSPECTED PRIOR TO RELEASE FROM BELMONT MEDICAL TECHNOLOGIES. A REVIEW OF PAST COMPLAINTS INDICATES THAT THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE RELATED TO THE POTENTIAL LOT NUMBERS INVOLVED IN THE INCIDENT. NO PATIENT INJURY WAS REPORTED. WE HAVE CONTACTED THE USER FACILITY TO OBTAIN THE SERIAL NUMBER OF THE RAPID INFUSER INVOLVED AND TO REQUEST THE DEVICE BACK FOR INVESTIGATION, IN ORDER TO DETERMINE IF THERE WERE ANY ANOMALIES WITH THE DEVICE. WITHOUT THE ABILITY TO INVESTIGATE THE DEVICE OR ASSOCIATED DISPOSABLE SET, THE ROOT CAUSE OF THE REPORTED SMOKE AND TEAR IN THE TUBING CANNOT BE ESTABLISHED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE FOLLOWING: "THE BELMONT WAS TRANSFUSING IN THE OPERATING ROOM. WE WERE ON THE SECOND BOX OF MTP WHEN THE MACHINE STARTED TO SMOKE FROM THE DOOR. WE STOPPED THE TRANSFUSION FROM THE BELMONT AND NOTICED BLOOD POOLING AND RUNNING OUT FROM THE BOTTOM OF THE DOOR. WE TURNED THE MACHINE OFF AND NOTICED THAT THE TUBING AT THE BOTTOM OF THE DOOR WAS SLIT OPEN. THERE WERE NO ISSUES WITH THE TRANSFUSION PRIOR TO THIS EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28660 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1