BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET

    MDR report key: 19811684 · Received July 23, 2024

    Report

    Report Number
    1219702-2024-00034
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 22, 2024
    Report Date
    July 23, 2024
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    FRN
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT FILE (B)(4) HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. BELMONT RECEIVED A REPORT FOR THIS INCIDENT ON JUNE 26TH, 2024. THE RI-2 INVOLVED IN THE INCIDENT WAS RETURNED TO BELMONT MEDICAL TECHNOLOGIES (UK) OFFICE AND THE USER CONFIRMED THAT THE DISPOSABLE SET INVOLVED IN THIS INCIDENT WAS DISCARDED THEREFORE COULD NOT BE SENT FOR REVIEW. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THIS 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. THE LOT NUMBER WAS UNKNOWN SO AN INVESTIGATION INTO THE LOT HISTORY COULD NOT BE PERFORMED. ALL DISPOSABLE SET ARE 100% LEAK TESTED AND VISUALLY INSPECTED PRIOR TO RELEASE. THE RAPID INFUSER INVOLVED WAS EVALUATED BY A BELMONT SERVICE TECHNICIAN (UK). ALL SENSORS WERE CLEANED AND CHECKED WITH NO ISSUES. THE DEVICE UNDERWENT A FULL SYSTEM TEST AND PASSED WITH NO ISSUES. NO DEVICE MALFUNCTION COULD BE VERIFIED, AND THE ROOT CAUSE OF THE ALLEGED LEAK COULD NOT BE DETERMINED. BELMONT WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT CLOSELY AND TAKE FURTHER CORRECTIVE AND PREVENTIVE ACTIONS IF REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE ADMINISTERING A MAJOR HAEMORRHAGE PROTOCOL (MHP), 2 BAGS OF BLOOD WERE SUCCESSFULLY TRANSFUSED AND THE SET-UP LOOKED OKAY. HOWEVER, WHEN TRANSFUSING THE THIRD BAG OF BLOOD IT WAS NOTED THAT BLOOD WAS LEAKING THROUGH THE DOOR? THE REPORTER WAS UNCERTAIN OF THE SOURCE OF THE LEAKAGE, BUT A SLIGHT GAPING WAS OBSERVED ON THE DOOR. THE INITIAL DEVICE WAS REPLACED AND THE REPLACEMENT DEVICE USED WITH THE SAME PROTOCOL ADMINISTERED AS PER PLAN AND PATIENT NEED. NO PATIENT HEALTH IMPACT OR CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964336 3-SPIKE DISPOSABLE SET PUMP, INFUSION FRN BELMONT MEDICAL TECHNOLOGIES 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown