BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, RI-2

    MDR report key: 19192019 · Received April 26, 2024

    Report

    Report Number
    1219702-2024-00018
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    February 16, 2024
    Report Date
    April 26, 2024
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    FRN
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGED INCIDENT WAS NOT REPORTED TO BELMONT OR OUR IMPORTER GALEN MEDICAL IN CANADA. BELMONT BECAME AWARE OF THE INCIDENT VIA A HEALTH CANADA USER FACILITY REPORT RECEIVED ON MARCH 27TH, 2024. THE INTERNAL COMPLAINT FILE #(B)(4) HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY ON THE DAY IT WAS RECEIVED AND THEREFORE SUBMITTING THIS NOW. THE RI-2 AND DISPOSABLE INVOLVED IN THE INCIDENT HAVE NOT BEEN RETURNED TO BELMONT MEDICAL TECHNOLOGIES FOR EVALUATION. THE USER FACILITY CONFIRMED APRIL 17TH, THAT THERE IS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT AND LOT NUMBER IS NOT AVAILABLE. 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 DISPOSABLE SETS ARE 100% LEAK TESTED AND VISUALLY INSPECTED PRIOR TO SALE. A SPIKE DISCONNECT IS VISIBLY OBVIOUS TO THE USER WHILE INTERACTING WITH THE SET. OTHER SPIKES CAN BE USED TO CONTINUE INFUSION. IN ADDITION, THE DISPOSABLE SET CAN BE EXCHANGED TO CONTINUE INFUSION. NO PATIENT IMPACT WAS NOTED AS A RESULT OF THE REPORTED INCIDENT. BELMONT REQUESTED ADDITIONAL INFORMATION FROM THE DISTRIBUTOR BUT, HAVE HAVE NOT RECEIVED ANY DETAILS TO DATE. WITHOUT RESULTS OF THE DEVICE INVESTIGATION, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AT BAY A3 USING BELMONT RAPID INFUSER TO ADMINISTER BLOOD RAPIDLY TO A PATIENT WHO WAS IN CRITICAL CONDITION, HAD AN ALARM TO RE PRIME, WHICH WAS DONE, THEN DURING TRANSFUSION IT APPEARS A PLASTIC PEG POPPED OUT, AND BLOOD SPRAYED ALL OVER, AND UNIT NO LONGER FUNCTIONING, STAFF HAD TO QUICKLY PRIME ANOTHER UNIT AND GET ANOTHER UNIT OF BLOOD TO GIVE TO THIS PATIENT WHO WAS IN CRITICAL CONDITION, NEEDING BLOOD QUICKLY, PATIENT UNABLE TO GET 1ST UNIT, AS IT SPRAYED ALL OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867100 THE BELMONT RAPID INFUSER, RI-2 THERMAL INFUSION FLUID WARMER FRN BELMONT MEDICAL TECHNOLOGIES 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown