BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM FLOW SENSOR (ACCESSORY TO QUANTUM PUMP CONSOLE)

    MDR report key: 21281084 · Received January 31, 2025

    Report

    Report Number
    3006073153-2025-00026
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 11, 2024
    Report Date
    January 31, 2025
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434422002
    PMA / PMN Number
    K173591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH DURING THE INVESTIGATION THE FLOW SENSOR APPEARED TO BE WORKING AND READING, OUT OF PRECAUTION THE SENSOR WAS DISPOSED OF AND REPLACED WITH A NEW ONE.

    Description of Event or Problem · 0

    THE LEVEL SENSOR'S LIGHTS WERE ON AND QWS SET TO SAFE FLOW LEVEL. THE PUMP RPM KICKED INTO FLOW REGULATION DURING PRIMING SEVERAL TIMES. THE PERFUSIONISTS REPLACED THE TAPE AND RESOLVED THIS ISSUE. HOWEVER, THIS HAPPENED AGAIN WHILE THEY WERE ON BYPASS. THE ALARM IS SHOWING FLASHING "S" BUT RPM NEVER DECREASED. ARTERIAL AND VENOUS FLOW STAYED STABLE DURING THESE EVENTS. THEY CHECKED THE CONNECTIONS AND MADE SURE EVERYTHING WAS CONNECTED TIGHTLY. THE PROBE DOESN'T HAVE VISIBLE DAMAGE WHEN THEY INSPECTED. THE LEVEL SENSOR WAS BEING USED FOR THE REST OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231713 QUANTUM FLOW SENSOR (ACCESSORY TO QUANTUM PUMP CONSOLE) FLOW SENSOR DRY SPECTRUM MEDICAL LTD QFS4 05060434422002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown