BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 11829475 · Received May 14, 2021

    Report

    Report Number
    1219702-2021-00068
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3-SPIKE DISPOSABLE SETS INVOLVED IN THE INCIDENT WERE DISCARDED AT THE HOSPITAL AND THEREFORE NOT AVAILABLE TO BE RETURNED TO BELMONT FOR INVESTIGATION. THE USER FACILITY WAS UNABLE TO PROVIDE THE ERROR MESSAGE ON THE SCREEN OR THE SERIAL NUMBER OF THE RAPID INFUSER, RI-2 USED IN THE PROCEDURE. WITHOUT INVESTIGATING THE UNIT A ROOT CAUSE CANNOT BE ESTABLISHED. THE MANUFACTURING BATCH RECORDS FOR THIS 3-SPIKE LOT NUMBER WERE REVIEWED AND NO RELATED ANOMALIES WERE IDENTIFIED. ALL 3-SPIKE DISPOSABLE SETS ARE 100% LEAK TESTED AND 100% VISUALLY INSPECTED PRIOR TO RELEASE FROM BELMONT MEDICAL TECHNOLOGIES. WE HAVE CONTACTED THE USER FACILITY TO DETERMINE THE ERROR MESSAGE DISPLAYED BY THE RI-2 AND THE SERIAL NUMBER OF THE UNIT. WITHOUT FURTHER INFORMATION IT IS DIFFICULT TO DETERMINE WHAT OCCURRED IN THIS CASE. A REVIEW OF PAST COMPLAINTS INDICATES NO OTHER REPORTS RELATED TO THIS LOT NUMBER. THERE WAS NO PATIENT INJURY REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RI-2 WAS EXPERIENCING AN ERROR WHICH WAS RESOLVED AFTER REPLACING THREE SETS OF THE 3-SPIKE DISPOSABLE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721736 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET 2021-01 02 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1