BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM LEVEL SENSOR

    MDR report key: 25296991 · Received May 27, 2026

    Report

    Report Number
    3006073153-2026-00139
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 27, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434420893
    PMA / PMN Number
    K173591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED LEVEL SENSOR EXPERIENCED A RECURRING LEVEL SENSOR ERROR DURING A COMPLEX CPB PROCEDURE AT GASLINI HOSPITAL, WITH MULTIPLE SENSOR TESTS AND SYSTEM ADJUSTMENTS MADE. THE PERFUSIONISTS EXPERIENCED REPEATED MASTER PUMP STOPS DUE TO FALSE LEVEL SENSOR ALARMS, DESPITE THE RESERVOIR HAVING SUFFICIENT FLUID LEVELS, AND ATTEMPTED TO DISABLE THE SENSOR WITHOUT SUCCESS. THE LOGS ANALYSIS SHOWED MULTIPLE INSTANCES OF ERRORS, SENSOR DISABLEMENT, AND RE-ENABLEMENT, WITH THE SENSOR APPEARING PHYSICALLY INTACT AND FUNCTIONING CORRECTLY DURING TESTS. SIMULATION OF THE CLINICAL CASE USING THE RETURNED COMPLAINED DEVICE WILL BE PERFORMED TO IDENTIFY THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    DURING THE EARLY PHASE OF EXTRACORPOREAL CIRCULATION, THE SAFE LEVEL SENSOR WAS TRIGGERED EVEN THOUGH THERE WAS STILL A SIGNIFICANT FLUID LEVEL IN THE CARDIOTOMY RESERVOIR. AFTER DISABLING THE LEVEL ALARM, THE MASTER PUMP STOPPED DUE TO ACTIVATION OF THE PROTECTED LEVEL ALARM, DESPITE THERE BEING NO ACTUAL LOW-FLUID CONDITION IN THE CARDIOTOMY RESERVOIR. THE PERFUSIONIST DECIDED TO USE THE HAND CRANK FOR ABOUT ONE MINUTE. THE CPB CASE WAS COMPLETED WITH NO ADVERSE EVENTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511441 QUANTUM LEVEL SENSOR LEVEL SENSOR DRY SPECTRUM MEDICAL LTD QLV1 05060434420893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention