BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, RI-2

    MDR report key: 17447349 · Received August 2, 2023

    Report

    Report Number
    1219702-2023-00037
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 1, 2023
    Report Date
    September 22, 2023
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    FRN
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON FURTHER FOLLOW-UP WITH THE USER FACILITY, IT WAS CONFIRMED THAT NO ADDITIONAL DETAILS WERE AVAILABLE. THE USER WAS PROVIDED WITH THE LATEST VERSION OF THE RI-2 QUICK REFERENCE GUIDE AND PROVIDED WITH RECOMMENDATIONS ON BEST PRACTICE USE OF THE RI-2. WE WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT CLOSELY AND TAKE FURTHER CORRECTIVE AND PREVENTIVE ACTIONS IF REQUIRED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT FILE #: (B)(4) HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. THE RI-2 AND DISPOSABLE INVOLVED IN THE INCIDENT WAS RETURNED TO BELMONT MEDICAL TECHNOLOGIES FOR EVALUATION ON JULY 7TH, 2023. NO PATIENT INJURY WAS REPORTED. 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. EVALUATION: UPON RECEIPT OF THE REFERENCED RAPID INFUSER RI-2 UNIT, BELMONT SERVICE ENGINEERS WERE UNABLE TO CONFIRM THE CUSTOMER COMPLAINT AFTER EXTENSIVE FUNCTIONAL TESTING AND STRESS TESTING AT ELEVATED TEMPERATURE FOR 48 HOURS. THERE WAS NO EVIDENCE OF ANY 'FIRE'. WE DOUBLE CHECKED BOTH INPUT AND OUTPUT TEMPERATURES, THE INPUT AND OUTPUT TEMPERATURE PROBES, THE POWER DRIVE MODULE ASSEMBLY, THE HEATER CONTROL BOARD, THE BOBBIN COIL ASSEMBLY, AND ALL CABLES IN THE SYSTEM FOR PROPER CONNECTIONS, AND THEY WERE ALL CONNECTED AND OPERATING PROPERLY. THE UNIT PERFORMED ACCORDING TO OUR SPECIFICATIONS UPON RECEIPT. 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. THE DISPOSABLE SET RETURNED WITH THE UNIT, WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THAT THE UPPER SECTION OF THE HEAT EXCHANGER WAS DEFORMED FROM EXCESSIVE HEAT DUE TO BLOOD CLOT. THIS DEFORMATION WOULD BE THE CAUSE OF ANY SMELL OF SMOKE AND NOT THE RI-2 UNIT. IT IS DIFFICULT TO DRAW A CONCLUSION REGARDING THE CAUSE OF BLOOD COAGULATION. THE ROOT CAUSE WAS UNKNOWN. ALL 3-SPIKE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK TESTED PRIOR TO FINAL PACKAGING AND RELEASE FOR SHIPMENT FROM BELMONT MEDICAL TECHNOLOGIES. WE ARE REACHING OUT TO THE USER FACILITY IN ORDER TO SCHEDULE A CALL AND GATHER ADDITIONAL DETAILS ON THE EVENT, A FOLLOW-UP REPORT WILL BE FILLED ONCE ADDITIONAL DETAILS ARE AVAILABLE.

    Description of Event or Problem · 0

    THE DEVICE THAT REPORTEDLY CAUGHT FIRE DURING A CASE ON SATURDAY, (B)(6). THE STAFF DID KEEP THE DISPOSABLE AND CAN SEND IT AS WELL IF NEEDED. ON FOLLOW-UP WITH (B)(6) (ASSISTANT PROFESSOR, DEPARTMENT OF ANESTHESIOLOGY) ON JULY 6TH, 2023, THE FOLLOWING WAS OUTLINED: THE BELMONT RAPID INFUSING DEVICE WAS PRIMED IN STANDARD FASHION, WITH 500 ML OF PRESERVATIVE FREE 0.9% NORMAL SALINE SOLUTION, BY ONE OF OUR ANESTHESIA TECHS PRIOR TO THE START OF THE PROCEDURE. THE BELMONT WAS FUNCTIONING WITHOUT ISSUE, ALBEIT AT A STEADY RELATIVELY HIGHER INFUSION RATE (100-250 ML/MIN, CONTINUOUSLY FOR A PERIOD), UNTIL APPROXIMATELY 00:50 ON (B)(6) 2023. AT THIS POINT I PERSONALLY SMELLED SMOKE, WAS CONCERNED FOR A POTENTIAL FIRE, ALERTED THE OPERATING ROOM OF SUCH, AND IMMEDIATELY IDENTIFIED IT WAS COMING FROM THE BELMONT MACHINE. THE BELMONT INFUSION WAS STOPPED IMMEDIATELY, DISCONNECTED FROM THE PATIENT, WITH THE EXTERNAL RESERVOIR WITH BLOOD PRODUCTS CLAMPED OFF FROM THE INTERNAL HEATING CORE. THERE WAS NO ERROR MESSAGE DISPLAYED ON THE BELMONT IMMEDIATELY PRECEDING THIS EVENT. EARLIER IN THE CASE, THERE WAS AN ALARM MESSAGE, BUT THIS WAS THE "HIGH PRESSURE" MESSAGE, WHICH WAS ADDRESSED BY OPENING THE DOOR AND ENSURING THERE WAS NO BLOCKAGE IN THE FLOW PATH, WITH NO ISSUE THEREAFTER. ON FURTHER FOLLOW-UP WITH THE USER FACILITY ON JULY 9TH, 2023, IT WAS FOUND THAT THE WHOLE BLOOD WAS NOT TRANSFUSED THROUGH THE DEVICE, INSTEAD PACKED RBC'S & FFP, WITH CELL SAVER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698617 THE BELMONT RAPID INFUSER, RI-2 PUMP INFUSION FRN BELMONT MEDICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown