BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, RI-2

    MDR report key: 16296645 · Received February 3, 2023

    Report

    Report Number
    1219702-2023-00013
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 3, 2023
    Report Date
    April 17, 2023
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    FRN
    PMA / PMN Number
    K141654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 HAVE NOT BEEN RETURNED TO BELMONT MEDICAL TECHNOLOGIES FOR EVALUATION. THE USER REPORTED OF A PLASTIC BURNING SMELL DURING THE INCIDENT IN THE LAST 15 MINUTES OF THE PROCEDURE. NO ERROR MESSAGE OR ALARM ON SCREEN AT THAT POINT. ONCE THEY STOPPED INFUSING AND OPENED THE DOOR, THEY DISCOVERED THAT THE DISPOSABLE SET WAS DEFORMED WITH BURNING SMELL FROM EXCESSIVE HEAT. THE DISPOSABLE AND THE DEVICE IS UNDER RISK MANAGEMENT CONTROL WITH THE USER DUE TO THE DEATH OF THE PATIENT INVOLVED. THERE ARE NO ALLEGATIONS THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH. 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. BELMONT IS WORKING WITH THE USER FACILITY TO GET THE DEVICE AND DISPOSABLE INVOLVED IN THIS INCIDENT RETURNED FOR INVESTIGATION. BELMONT'S CLINICAL SPECIALIST WILL BE VISITING THE USER FACILITY ON FEBRUARY 7TH, 8TH AND 9TH TO PROVIDE HOSPITAL STAFF REFRESHER TRAINING ON THE DEVICE AND GATHER ADDITIONAL DETAILS ON THE EVENT. 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.

    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 PERFORMED ACCORDING TO OUR SPECIFICATIONS UPON RECEIPT. THE 3-SPIKE DISPOSABLE SET WAS NOT RETURNED TO BELMONT FOR EVALUATION AND THE 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, APPEARS TO SHOW BLOOD CLOT AND DEFORMED. 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. A THOROUGH INVESTIGATION INTO THE INCIDENT IS NOT POSSIBLE SINCE THE DISPOSABLE SET WAS NOT RETURNED, AND THE MANUFACTURING LOT NUMBER OF THE DISPOSABLE SET IS NOT AVAILABLE. ALL 3-SPIKE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK TESTED PRIOR TO FINAL PACKAGING AND RELEASE FOR SHIPMENT FROM BELMONT MEDICAL TECHNOLOGIES. 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 AND 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. BELMONT CONDUCTED REFRESHER TRAINING FOR CLINICAL STAFF AT THE USER FACILITY ON FEBRUARY 8TH AND 9TH IN ORDER TO DEMONSTRATE THE PROPER USE OF DEVICE PER OUR SPECIFICATIONS. WE ALSO PROVIDED THEM WITH THE MOST UP TO DATE QUICK REFERENCE GUIDE THAT DETAILS SET UP AND LISTS COMPATIBLE FLUIDS. 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 OF A PLASTIC BURNING SMELL DURING THE INCIDENT IN THE LAST 15 MINUTES OF THE PROCEDURE. NO ERROR MESSAGE OR ALARM ON SCREEN AT THAT POINT. ONCE THEY STOPPED INFUSING AND OPENED THE DOOR, THEY DISCOVERED THAT THE DISPOSABLE SET WAS DEFORMED WITH BURNING SMELL FROM EXCESSIVE HEAT. THE DISPOSABLE AND THE DEVICE IS UNDER RISK MANAGEMENT CONTROL WITH THE USER DUE TO THE DEATH OF THE PATIENT INVOLVED. THERE ARE NO ALLEGATIONS THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991571 THE BELMONT RAPID INFUSER, RI-2 PUMP INFUSION FRN BELMONT MEDICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown