BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 11440986 · Received March 8, 2021

    Report

    Report Number
    1219702-2021-00035
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3-SPIKE DISPOSABLE SET INVOLVED IN THE INCIDENT WAS DISCARDED AT THE HOSPITAL AND THE USERS WERE UNABLE TO PROVIDE THE LOT NUMBER OF THE SET, THEREFORE A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. WITHOUT RECEIVING THE SAMPLE OR PHOTOGRAPHS FOR INVESTIGATION, A ROOT CAUSE OF THE REPORTED LEAK CANNOT BE ESTABLISHED. ALL 3-SPIKE DISPOSABLE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK-TESTED PRIOR TO RELEASE FROM BELMONT MEDICAL TECHNOLOGIES. NO PATIENT INJURY WAS REPORTED. WITHOUT THE ABILITY TO INVESTIGATE THE DISPOSABLE SET OR ASSOCIATED LOT NUMBER, IT IS DIFFICULT TO DETERMINE WHAT OCCURRED IN THIS CASE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. WE WILL CONTINUE TO MONITOR AND TREND SIMILAR REPORTS OF THIS NATURE AND TAKE FURTHER ACTION IF REQUIRED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE 3-SPIKE DISPOSABLE SET LEAKED BLOOD DURING A CASE WITH A RAPID INFUSER, RI-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330063 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1