BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM WORKSTATION (QUANTUM PUMP CONSOLE)

    MDR report key: 21272235 · Received January 30, 2025

    Report

    Report Number
    3006073153-2025-00020
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    October 19, 2023
    Report Date
    January 30, 2025
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    UDI-DI
    05060434420008
    PMA / PMN Number
    K163657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPOSSIBLE TO ACTIVATE SWEEP WHILE GOING ON BYPASS. SWEEP FLOW REMAINED 'BLINKING' ON QVM. NO INFORMATION RECEIVED IF QWS PATIENT MANAGER WAS USED AS WELL OR NOT. PERFUSIONIST PANICKED AND WEANED BACK FROM BYPASS, HAS CHANGED THE WHOLE QUANTUM CONSOLE FOR A BACKUP S5 AND FINISHED PROCEDURE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792286 QUANTUM WORKSTATION (QUANTUM PUMP CONSOLE) HEART LUNG MACHINE DTQ SPECTRUM MEDICAL LTD QWS 05060434420008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening