BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM SMART OCCLUDER - LH

    MDR report key: 23436263 · Received October 31, 2025

    Report

    Report Number
    3006073153-2025-00278
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 17, 2025
    Report Date
    February 23, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD.
    Product Code
    DTQ
    UDI-DI
    05060434424044
    PMA / PMN Number
    K190282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CONTINUED TO BE USED AFTER THE INCIDENT, WITH NO FURTHER ISSUES. DEVICE BEING RETURNED TO MANUFACTURER, TO BE INVESTIGATED ON RETURN.

    Additional Manufacturer Narrative · 0

    DEVICE CONTINUED TO BE USED AFTER THE INCIDENT, WITH NO FURTHER ISSUES. DEVICE BEING RETURNED TO MANUFACTURER, TO BE INVESTIGATED ON RETURN. FOLLOW UP ON 19-DEC-2025: RETURN OF SUBJECT DEVICE TO MANUFACTURER, LOANER PROVIDED TO CUSTOMER. TESTING OF SUBJECT DEVICE STILL ONGOING.

    Additional Manufacturer Narrative · 0

    DEVICE CONTIUED TO BE USED AFTER THE INCIDENT, WITH NO FURTHER ISSUES. DEVICE BEING RETURNED TO MANUFACTURER, TO BE INVESTIGATED ON RETURN. FOLLOW UP 19-DEC-2025: RETURN OF SUBJECT DEVICE TO MANUFACTURER, LOANER PROVIDED TO CUSTOMER. TESTING OF SUBJECT DEVICE STILL ONGOING FINAL 23-FEB-2026: INVESTIGATION AT SPECTRUM MEDICAL ITALY - COULD NOT REPRODUCE ERROR OF THE OCCLUDER NOT OPENING. NO ELECTRICAL OR MECHANICAL ISSUES IDENTIFIED. DEVICE SENT TO SPECTRUM MEDICAL UK FOR FURTHER ANALYSIS INVESTIGATION AT SPECTRUM MEDICAL UK - MULTIPLE TEST REALISED CONSIDERING: SEVERAL FLOW SETPOINTS, ENDURANCE TESTING (OPEN\CLOSURE MULTIPLE CYCLES), PROLONGED OCCLUSION STATUS. ADDITIONALLY, COMPLETE ANALYSIS AND INSPECTION OF THE DEVICE HAS BEEN PERFORMED. OCCLUDER NOT OPENING ERROR COULD NOT BE REPRODUCED AFTER TESTING THROUGH FULL RANGE OF OPERATION. INTERNAL INSPECTION COMPLETED, NO ISSUES IDENTIFIED. ROOT CAUSE DETERMINED TO BE USER MISUSE CAUSING A RARE MECHANICAL ANOMALY, NOT REPRODUCIBLE UNDER STANDARD CONDITIONS.

    Description of Event or Problem · 0

    SPECTRUM MEDICAL STAFF WAS PRESENT TO TRAIN THE PERFUSIONISTS IN THE 3RD WEEK OF INSTALLATION. THE SYSTEM WAS SET CORRECTLY AND IN INITIATION MODE. BEFORE STARTING WITH CPB, 50ML WAS GIVEN FOR 2-3 TIMES AND ALL WAS GOOD. WHEN THE PERFUSIONIST STARTED BYPASS AND INCREASED THE FLOW, THE VEIN QSO WAS OPENED TO PRODUCE A MINIMAL FLOW, BUT THE ARTERY QSO DID NOT OPEN (LED FLASHING). THEY DECIDED TO EXIT FROM THE INITIATION MODE, AND THE VEIN OCCLUDER WENT TO A FULLY OPEN POSITION, HOWEVER THE ARTERY OCCLUDER REMAINED CLOSED. FLOW WAS STOPPED, SPECTRUM MEDICAL STAFF REMOVED THE TUBES MANUALLY FROM THE QSO AND THE FLOW TO THE PATIENT WAS RESTORED. AFTER THAT, THE PERFUSIONIST WANTED TO REUSE THE ARTERIAL QSO. BEFORE REINSERTING THE TUBE IN THE QSO, THEY DID THE CARRIAGE TEST AND THE FUNCTION WAS OK. AFTER THAT, ALL THE FEATURES WERE CORRECT AND THEY USED THE QSO UNTIL THE END OF THE OPERATION WITH NO FURTHER ISSUES.

    Description of Event or Problem · 0

    SPECTRUM MEDICAL STAFF WAS PRESENT TO TRAIN THE PERFUSIONISTS IN THE 3RD WEEK OF INSTALLATION. THE SYSTEM WAS SET CORRECTLY AND IN INITIATION MODE. BEFORE STARTING WITH CPB, 50ML WAS GIVEN FOR 2-3 TIMES AND ALL WAS GOOD. WHEN THE PERFUSIONIST STARTED BYPASS AND INCREASED THE FLOW, THE VEIN QSO WAS OPENED TO PRODUCE A MINIMAL FLOW, BUT THE ARTERY QSO DID NOT OPEN (LED FLASHING). THEY DECIDED TO EXIT FROM THE INITIATION MODE, AND THE VEIN OCCLUDER WENT TO A FULLY OPEN POSITION, HOWEVER THE ARTERY OCCLUDER REMAINED CLOSED. FLOW WAS STOPPED, SPECTRUM MEDICAL STAFF REMOVED THE TUBES MANUALLY FROM THE QSO AND THE FLOW TO THE PATIENT WAS RESTORED. AFTER THAT, THE PERFUSIONIST WANTED TO REUSE THE ARTERIAL QSO. BEFORE REINSERTING THE TUBE IN THE QSO, THEY DID THE CARRIAGE TEST AND THE FUNCTION WAS OK. AFTER THAT, ALL THE FEATURES WERE CORRECT AND THEY USED THE QSO UNTIL THE END OF THE OPERATION WITH NO FURTHER ISSUES.

    Description of Event or Problem · 0

    SPECTRUM MEDICAL STAFF WAS PRESENT TO TRAIN THE PERFUSIONISTS IN THE 3RD WEEK OF INSTALLATION. THE SYSTEM WAS SET CORRECTLY AND IN INITIATION MODE. BEFORE STARTING WITH CPB, 50ML WAS GIVEN FOR 2-3 TIMES AND ALL WAS GOOD. WHEN THE PERFUSIONIST STARTED BYPASS AND INCREASED THE FLOW, THE VEIN QSO WAS OPENED TO PRODUCE A MINIMAL FLOW, BUT THE ARTERY QSO DID NOT OPEN (LED FLASHING). THEY DECIDED TO EXIT FROM THE INITIATION MODE, AND THE VEIN OCCLUDER WENT TO A FULLY OPEN POSITION, HOWEVER THE ARTERY OCCLUDER REMAINED CLOSED. FLOW WAS STOPPED, SPECTRUM MEDICAL STAFF REMOVED THE TUBES MANUALLY FROM THE QSO AND THE FLOW TO THE PATIENT WAS RESTORED. AFTER THAT, THE PERFUSIONIST WANTED TO REUSE THE ARTERIAL QSO. BEFORE REINSERTING THE TUBE IN THE QSO, THEY DID THE CARRIAGE TEST AND THE FUNCTION WAS OK. AFTER THAT, ALL THE FEATURES WERE CORRECT AND THEY USED THE QSO UNTIL THE END OF THE OPERATION WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540978 QUANTUM SMART OCCLUDER - LH ELECTRONIC TUBE CLAMP DTQ SPECTRUM MEDICAL LTD. QSOL 05060434424044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown