BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID INFUSER RI-2, 120V, 1000ML/MIN

    MDR report key: 21536172 · Received March 6, 2025

    Report

    Report Number
    1219702-2025-00016
    Event Type
    Injury
    Date Received
    March 6, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    10896128002630
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT FILE (B)(4) HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. THE RI-2 AND DISPOSABLE INVOLVED IN THE INCIDENT HAVE NOT YET BEEN RETURNED TO BELMONT MEDICAL TECHNOLOGIES FOR EVALUATION. THE USER INDICATED THAT AIR WAS REMOVED BY HAND AND THE DEVICE OPERATED PROPERLY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. ALL DISPOSABLE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK TESTED PRIOR TO FINAL PACKAGING AND RELEASE FOR SHIPMENT FROM BELMONT MEDICAL TECHNOLOGIES. BELMONT IS WORKING WITH THE USER FACILITY TO GET THE DEVICE INVOLVED IN THIS INCIDENT RETURNED FOR INVESTIGATION. WITHOUT RESULTS OF THE DEVICE INVESTIGATION, NO CONCLUSIONS CAN BE DRAWN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE REFERENCED RAPID INFUSER RI-2 UNIT, THE DEVICE WAS EVALUATED BY A BELMONT SERVICE TECHNICIAN, AND WE WERE UNABLE TO CONFIRM THE CITED AIR IN LINE ERROR AFTER EXTENSIVE FUNCTIONAL TESTING AND STRESS TESTING AT ELEVATED TEMPERATURE FOR 48 HOURS. THE UNIT EXHIBITED NO FAULTS/FAILURES. THE DEVICE HISTORY WAS REVIEWED FOR THIS UNIT, AND NO OTHER ISSUES WERE IDENTIFIED. TO ENSURE THAT THIS UNIT PERFORMS ACCORDING TO OUR SPECIFICATIONS BEFORE SHIPPING IT BACK, WE PERFORMED A FINAL FUNCTIONAL TEST, AN ELECTRICAL SAFETY TEST, A BATTERY TEST, AND A FINAL INSPECTION. THE UNIT PASSED ALL TEST SPECIFICATIONS AND INSPECTION REQUIREMENTS. IT WAS FOUND THE REPORTED ISSUE COULD NOT BE CONFIRMED AFTER EXTENSIVE FUNCTIONAL TESTING. THE AIR DETECTOR ALARM FUNCTIONED WITH NO ISSUE. NO DEVICE MALFUNCTION COULD BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR THESE INCIDENTS GOING FORWARD.

    Description of Event or Problem · 0

    THE BIOMED REPORTED THAT, "BELMONT RAPID INFUSER RI-2 HAVING, SN: (B)(6), REF 903-00039 RECENTLY HAD AN ISSUE WHERE A LINE INTO THE RESERVOIR CLOTTED OFF. WHEN THE INTAKE CLOTTED OFF, A SIGNIFICANT AMOUNT OF AIR WAS ENTRAINED INTO THE SYSTEM. IT WAS NOT CAUGHT BY THE AIR SENSOR AND MADE IT INTO THE PATIENT LINE. THE MACHINE WAS STOPPED PRIOR TO IT GOING TO THE PATIENT. THE AIR WAS REMOVED BY HAND AND THE MACHINE OPERATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812084 RAPID INFUSER RI-2, 120V, 1000ML/MIN THERMAL INFUSION FLUID LGZ BELMONT MEDICAL TECHNOLOGIES 903-00037 10896128002630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown