BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, RI-2

    MDR report key: 16118492 · Received January 6, 2023

    Report

    Report Number
    1219702-2023-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 8, 2022
    Report Date
    March 7, 2023
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    FRN
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 BIOMED REPORTED THAT SMOKING AND LEAKING APPEARED TO OCCUR PRETTY MUCH SIMULTANEOUSLY AND WERE NOTED BY BOTH TRAUMA AND IR STAFF. THE UNIT WAS IMMEDIATELY CUT OFF, DISCONNECTED AND REMOVED FROM SERVICE, AWAY FROM PATIENT. THIS UNIT/MACHINE WAS USED THE DAY PRIOR IN A MASSIVE WITHOUT INCIDENT. ONLY SALINE, PRBC AND FFP WERE INFUSED WHICH ARE ALL APPROVED SOLUTIONS (NO WHOLE BLOOD ON THIS MASSIVE). PATIENT WAS TAKEN TO OR WHERE MASSIVE PROTOCOL WAS CONTINUED WITH A DIFFERENT MACHINE/UNIT. ALTHOUGH THE PATIENT INVOLVED IN THE INCIDENT DIED, THERE ARE NO ALLEGATIONS THAT THE DEVICE CONTRIBUTED TO 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 INVOLVED IN THIS INCIDENT RETURNED FOR INVESTIGATION. A CLINICAL SPECIALIST (FROM BELMONT MEDICAL TECHNOLOGIES) WILL BE VISITING THE USER FACILITY TO TRAIN THE HOSPITAL STAFF FOR REFRESHER TRAINING ON THE DEVICE AND GATHER ADDITIONAL DETAILS ON THE EVENT. WITHOUT RESULTS OF THE DEVICE INVESTIGATION, NO CONCLUSIONS CAN BE DRAWN. 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 (B)(6) INVOLVED IN THE INCIDENT WAS RETURNED TO BELMONT MEDICAL TECHNOLOGIES FOR EVALUATION, HOWEVER THE DISPOSABLE INVOLVED IN THE INCIDENT WAS NOT RETURNED, IT WAS DISCARDED. ALTHOUGH THE PATIENT INVOLVED IN THE INCIDENT DIED, IT WAS DETERMINED THE DEVICE DID NOT PLAY A ROLE IN THE DEATH. THE BELMONT SERVICE ENGINEERS WERE UNABLE TO CONFIRM THE CUSTOMER COMPLAINT AFTER EXTENSIVE FUNCTIONAL TESTING OF THE SYSTEM. THEY ALSO DOUBLE CHECKED BOTH INPUT AND OUTPUT TEMPERATURES, THE INPUT AND OUTPUT TEMPERATURE PROBES, THE POWER DRIVE MODULE ASSEMBLY, THE BOBBIN ASSEMBLY, AND ALL CABLES IN THE SYSTEM FOR PROPER CONNECTIONS, AND THEY WERE ALL CONNECTED AND OPERATED PROPERLY AND FOUND THAT 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. BELMONT CONDUCTED REFRESHER TRAINING FOR CLINICAL STAFF AT THE USER FACILITY ON JANUARY 18TH AND 19TH 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. THE DISPOSABLE SET WAS NOT RETURNED TO BELMONT FOR EVALUATION; THEREFORE, A THOROUGH INVESTIGATION INTO THE DISPOSABLE SET IS NOT POSSIBLE. ALL 3-SPIKE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK TESTED PRIOR TO FINAL PACKAGING AND RELEASE FOR SHIPMENT FROM BELMONT MEDICAL TECHNOLOGIES. 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 BIOMED REPORTED THAT SMOKING AND LEAKING APPEARED TO OCCUR PRETTY MUCH SIMULTANEOUSLY AND WERE NOTED BY BOTH TRAUMA AND IR STAFF. THE UNIT WAS IMMEDIATELY CUT OFF, DISCONNECTED AND REMOVED FROM SERVICE, AWAY FROM PATIENT. THIS UNIT/MACHINE WAS USED THE DAY PRIOR IN A MASSIVE WITHOUT INCIDENT. ONLY SALINE, PRBC AND FFP WERE INFUSED WHICH ARE ALL APPROVED SOLUTIONS (NO WHOLE BLOOD ON THIS MASSIVE). PATIENT WAS TAKEN TO OR WHERE MASSIVE PROTOCOL WAS CONTINUED WITH A DIFFERENT MACHINE/UNIT. ALTHOUGH THE PATIENT INVOLVED IN THE INCIDENT DIED, THERE ARE NO ALLEGATIONS THAT THE DEVICE CONTRIBUTED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634462 THE BELMONT RAPID INFUSER, RI-2 PUMP INFUSION FRN BELMONT MEDICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown