BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, RI-2

    MDR report key: 16211377 · Received January 19, 2023

    Report

    Report Number
    1219702-2023-00012
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 20, 2022
    Report Date
    March 17, 2023
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    FRN
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 INVOLVED IN THE INCIDENT HAS BEEN RETURNED TO BELMONT MEDICAL TECHNOLOGIES FOR EVALUATION ON 12/28/2022. THE USER REPORTED THAT RI-2 WAS EXPERIENCING OVERHEAT ALARM AND THEN SMOKE COMING OUT OF THE HEAT EXCHANGE IN THE MIDDLE OF THE CASE. THE USER WAS TRANSFUSING COLD PRODUCTS- RBC'S AND LP (LIQUID PLASMA), AND WAS PROBABLY ON ABOUT THE 5TH COOLER AT THAT POINT. THE INCIDENT OCCURRED DURING THE MIDDLE OF OPERATION. THE USER CONFIRMED THAT THERE WAS NO BLOOD IN THE CHAMBER OR AROUND THE HEATING COIL, UNTIL THE PLASTIC MELTED AND STARTED LEAKING INSIDE. WHEN THE RAPID INFUSER DETECTS A SITUATION THAT IS COMPROMISING EFFECTIVE INFUSING, THE SYSTEM STOPS PUMPING AND HEATING, CLOSES OFF THE LINE TO THE PATIENT, SOUNDS AN AUDIBLE ALARM, AND DISPLAYS AN ALARM MESSAGE WITH INSTRUCTIONS FOR CORRECTIVE MEASURE. IN THE EVENT OF AN "OVER TEMPERATURE" ALARM, THE RAPID INFUSER DISPLAYS THE FOLLOWING ALARM MESSAGE: "INFUSATE OVER TEMPERATURE. DISCARD DISPOSABLE AND BLOOD. RESTART SYSTEM WITH A NEW DISPOSABLE. SERVICE MACHINE IF ERROR PERSISTS."THE OPERATOR'S MANUAL ALSO PROVIDES POSSIBLE CONDITIONS AND ADDITIONAL RECOMMENDED OPERATOR ACTIONS.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 EVALUATION OF THE DEVICE EXHIBITED NO FAULTS/FAILURES. THE UNIT PERFORMED ACCORDING TO OUR SPECIFICATIONS UPON RECEIPT. BELMONT SERVICE DEPARTMENT UPGRADED THE SYSTEM TO THE LATEST SOFTWARE REVISION. TO ENSURE THAT THIS UNIT PERFORMS ACCORDING TO OUR SPECIFICATIONS, IT WAS OPERATED AT ELEVATED TEMPERATURE FOR 48 HOURS. UPON COMPLETION, A FINAL FUNCTIONAL TEST, AN ELECTRICAL SAFETY TEST, AND A FINAL INSPECTION WERE PERFORMED. THE UNIT PASSED ALL TEST SPECIFICATIONS AND INSPECTION REQUIREMENTS. WE WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT. THE USER HAS BEEN REQUESTED TO CONFIRM THE PATIENT STATUS, LOT NUMBER OF THE DISPOSABLE AND CONFIRM IF THE DISPOSABLE INVOLVED IN THIS INVESTIGATION WAS DISCARDED (DEC 22ND AND JAN 16TH). A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE RI-2 WITH S/N:(B)(6) INVOLVED IN THE INCIDENT WAS RETURNED TO BELMONT MEDICAL TECHNOLOGIES FOR EVALUATION, HOWEVER THE DISPOSABLE INVOLVED IN THE INCIDENT WAS NOT RETURNED. UPON RECEIPT OF THE REFERENCED RAPID INFUSER, RI-2 UNIT, THE SERVICE DEPARTMENT WERE UNABLE TO CONFIRM THE CUSTOMER COMPLAINT OF AN OVERHEATED / OVER TEMPERATURE ISSUE AFTER EXTENSIVE FUNCTIONAL TESTING AND STRESS TESTING AT ELEVATED TEMPERATURE FOR 48 HOURS. THEY ALSO DOUBLE CHECKED BOTH INPUT AND OUTPUT TEMPERATURES, THE INPUT AND OUTPUT TEMPERATURE PROBES, THE POWER DRIVE MODULE ASSEMBLY, AND ALL CABLES IN THE SYSTEM FOR PROPER CONNECTIONS, AND THEY WERE ALL CONNECTED AND OPERATED PROPERLY. THE UNIT PASSED ALL TEST SPECIFICATIONS AND INSPECTION REQUIREMENTS. THE 3-SPIKE DISPOSABLE SET WAS NOT RETURNED TO BELMONT FOR EVALUATION AND LOT NUMBER WAS NOT AVAILABLE. BASED ON THE REVIEW OF 3-SPIKE DISPOSABLE PHOTOS PROVIDED BY THE USER FACILITY, IT WAS FOUND THAT UPPER SECTION OF THE HEAT EXCHANGER, AT THE AREA WHERE THE OUTPUT TEMPERATURE PROBE IS LOCATED, WAS DEFORMED DUE TO OVERHEATING CAUSED BY BLOOD CLOTTING. CERTAIN INFUSATES ARE CONTRAINDICATED AND MAY LEAD TO CLOT FORMATION INSIDE THE HEAT EXCHANGER, WHICH CAN BLOCK BLOOD FLOW AND RESULT IN AN "OVER TEMPERATURE" ALARM. THE ONLY KNOWN WAY TO CAUSE COAGULATION IN CITRATED BLOOD IS TO MIX LACTATED RINGER'S OR OTHER SOLUTIONS CONTAINING CALCIUM WITH CITRATED BLOOD PRODUCTS. ONLY ANTI-COAGULATED BLOOD PRODUCTS ARE APPROVED FOR USE, AND IT IS NOT INTENDED TO BE USED FOR DRUG ADMINISTRATION. THE DISPOSABLE SET WAS NOT RETURNED TO BELMONT FOR EVALUATION; THEREFORE, A THOROUGH INVESTIGATION INTO THE DISPOSABLE SET IS NOT POSSIBLE. BELMONT SERVICE DEPARTMENT CLEANED BOTH INPUT AND OUTPUT TEMPERATURE PROBES AND UPGRADED THE SYSTEM TO THE CURRENT REVISION. TO ENSURE THAT THE UNIT PERFORMS ACCORDING TO OUR SPECIFICATIONS BEFORE SHIPPING IT BACK, WE PERFORMED A ROUTINE CALIBRATION OF THE SYSTEM, OPERATED THE UNIT AT ELEVATED TEMPERATURE FOR 48 HOURS. UPON COMPLETION, A FINAL FUNCTIONAL TEST, AN ELECTRICAL SAFETY TEST, AND A FINAL INSPECTION WERE PERFORMED. THE UNIT PASSED ALL TEST SPECIFICATIONS AND INSPECTION REQUIREMENTS. ALTHOUGH NO DEVICE MALFUNCTION COULD BE VERIFIED, BELMONT HAS OPENED A CORRECTIVE ACTION TO FURTHER INVESTIGATE AND ADDRESS THIS REPORTED ISSUE. ALL 3-SPIKE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK TESTED PRIOR TO FINAL PACKAGING AND RELEASE FOR SHIPMENT FROM BELMONT MEDICAL TECHNOLOGIES. IN ORDER TO ENSURE THAT THE BELMONT'S DEVICE IS USED AS INTENDED BY THE USER FACILITY, BELMONT'S CLINICAL SPECIALIST REACHED OUT THE USER FACILITY TO OFFER A REFRESHER TRAINING BUT, HAVEN'T RECEIVED ANY CONFIRMATION AS OF MARCH 17TH. NO DEVICE MALFUNCTION COULD BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. BELMONT WILL CONTINUE TO MONITOR THIS ISSUE MOVING FORWARD.

    Description of Event or Problem · 0

    THE USER REPORTED THAT RI-2 WAS EXPERIENCING OVERHEAT ALARM AND THEN SMOKE COMIN GOUT OF THE HEAT EXCHANGE IN THE MIDDLE OF THE CASE. ACCORDING TO THE REPORT, THE DEVICE HAD AN OVERHEATING ALAM AS WELL AS STARTED TO SMOKE. THE USER WAS TRANSFUSING COLD PRODUCTS- RBC'S AND LP (LIQUID PLASMA), AND WAS PROBABLY ON ABOUT THE 5TH COOLER AT THAT POINT. THE INCIDENT OCCURED DURING THE MIDDLE OF OPERATION WHERE USER WAS JUST CONTINUING TO HANG PRODUCT AS THE USUAL PROCESS DURING THE PROCEDURE. THE USER CONFIRMED THAT THERE WAS NO BLOOD IN THE CHAMBER OR AROUND THE HEATING COIL, UNTIL IT BURNED THROUGH THE PLASTIC AND STARTED LEAKING INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113579 THE BELMONT RAPID INFUSER, RI-2 PUMP INFUSION FRN BELMONT MEDICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown