BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET

    MDR report key: 21322631 · Received February 6, 2025

    Report

    Report Number
    1219702-2025-00008
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 6, 2025
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    10896128002029
    PMA / PMN Number
    K242735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERNAL COMPLAINT FILE (B)(4). HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. THE RI-2 AND DISPOSABLE INVOLVED IN THE INCIDENT HAS NOT BEEN RETURNED TO BELMONT MEDICAL TECHNOLOGIES FOR EVALUATION. THE USER FACILITY CONFIRMED THAT THE DISPOSABLE SET INVOLVED IN THIS INCIDENT WAS DISCARDED THEREFORE COULD NOT BE SENT FOR REVIEW. THE USER WILL LOSE THE ABILITY TO INFUSE THE PATIENT WITH THE AFFECTED SPIKES. OTHER SPIKES CAN BE USED TO INFUSE THE PATIENT AND THE DISPOSABLE SET CAN BE EXCHANGED TO CONTINUE INFUSION. NO PATIENT IMPACT WAS NOTED AS A RESULT OF THE REPORTED INCIDENT. THE OPERATOR'S MANUAL PROVIDES INSTRUCTIONS ON INSTALLING THE DISPOSABLE SET AND ADDITIONAL RECOMMENDED OPERATOR ACTIONS. THE STEP-BY-STEP PROCEDURES IN MANUAL HAS WARNING ON INSTALLING THE DISPOSABLE, "DO NOT KINK OR TWIST THE TUBING" AND "DO NOT APPLY EXCESSIVE PRESSURE TO THE PRESSURE TRANSDUCER. THE PRESSURE TRANSDUCER CAN BE DAMAGED WITH EXCESSIVE FORCE. DO NOT USE THE SYSTEM IF THE PRESSURE TRANSDUCER IS DAMAGED". ALL 3- SPIKE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK TESTED PRIOR TO FINAL PACKAGING AND RELEASE FOR SHIPMENT FROM BELMONT MEDICAL TECHNOLOGIES. THE CITED DISPOSABLE SET WAS DISCARDED AND COULD NOT BE SENT FOR INVESTIGATION. AN INVESTIGATION INTO THE LOT HISTORY FOR LOT 20240213 WAS PERFORMED. AND THE RETAIN SAMPLE WAS INSPECTED. NO ISSUES WERE NOTED ON THE RETAIN SAMPLE AND NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT. ALL DISPOSABLE SET ARE 100% LEAK TESTED AND VISUALLY INSPECTED PRIOR TO RELEASE. THE USER CONFIRMED THAT THERE WAS NO PATIENT HARM AS A RESULT OF THE ALLEGED INCIDENT. THE ROOT CAUSE OF THE ALLEGED INCIDENT COULD NOT BE DETERMINED. TESTING OF A DEVICE FROM THE SAME LOT WAS CONDUCTED AND NO ISSUES WERE FOUND. NO DEVICE MALFUNCTION COULD BE VERIFIED, AND THE ROOT CAUSE OF THE ALLEGED INCIDENT COULD NOT BE DETERMINED. NO PATIENT HARM WAS CONFIRMED BY THE USER. BELMONT WILL CONTINUE TO MONITOR THIS ISSUE MOVING FORWARD.

    Description of Event or Problem · 0

    BELMONT RECEIVED MIR REPORT ON 1/7/2025. DETAILING THE FOLLOWING. BELMONT RAPID INFUSER GIVING SET USED TO INFUSE APPROXIMATELY 40 UNITS OF BLOOD PRODUCTS, TOWARDS THE END OF USE THE GIVING SET CAME APART AT TWO OF THE THREE BAG SPIKES ON THE INFUSION LINE. BELMONT HAS RECEIVED CONFIRMATION THAT THERE WAS NO IMPACT / HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918951 3-SPIKE DISPOSABLE SET THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES 903-00006 20240213 10896128002029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown