BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM SMART OCCLUDER - RIGHT HAND

    MDR report key: 25112317 · Received May 7, 2026

    Report

    Report Number
    3006073153-2026-00127
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 7, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    UDI-DI
    05060434423443
    PMA / PMN Number
    K190282
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AWAITING THE RETURN OF THE DEVICE FOR CONDUCT THE INVESTIGATION.

    Description of Event or Problem · 0

    PERFUSIONIST CLOSED THE OCCLUDER COMPLETELY DURING BYPASS TO TRANSLOCATE VOLUME TO THE PATIENT (NORMAL FLOW MODE). WHEN TRIED TO OPEN THE OCCLUDER, THIS REMAINED IN CLOSED POSITION, BUT THE QWS SHOWED THAT IT HAD OPENED. AFTER THAT, THE USER MANUALLY OPENED THE OCCLUDER (PUSH IN AND TURN BOBBINS), TESTED IT AND USED IT AGAIN. DURING WEANING MODE, THE SAME ISSUE OCCURRED. AS A RESULT CIRCULATION OF THE PATIENT WAS STOPPED BRIEFLY (APPROXIMATELY 1 MIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533997 QUANTUM SMART OCCLUDER - RIGHT HAND CARDIOPULMONARY BYPASS SYSTEM AIR BUBBLE/FLUID LEVEL DETECTOR DTQ SPECTRUM MEDICAL LTD QSOR 05060434423443

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention