BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM ROLLER PUMP (PART OF QUANTUM PUMP CONSOLE)

    MDR report key: 20187978 · Received September 11, 2024

    Report

    Report Number
    3006073153-2024-00057
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    July 30, 2024
    Report Date
    September 10, 2024
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    UDI-DI
    05060434420787
    PMA / PMN Number
    K173834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON ARRIVAL AT SPECTRUM MEDICAL INC THE REPORTED FAULT WAS CONFIRMED THE LEFT SIDE BOBBIN WAS NOT LOCKING. SPECTRUM MEDICAL INC SERVICE ENGINEER (SMSE) PERFORMED THE REMOVAL AND REPLACEMENT OF THE LEFT AND RIGHT BOBBIN PAWL, RATCHET, AND SPRING KIT.

    Description of Event or Problem · 0

    REPORTED THAT WHEN ADDING TENSION TO TUBING FOR CARDIOPLEGIA, THE BOBBINS STRIP AND DON'T REMAIN IN PLACE DESPITE THE LOCKING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588765 QUANTUM ROLLER PUMP (PART OF QUANTUM PUMP CONSOLE) ROLLER PUMP DTQ SPECTRUM MEDICAL LTD QRP6 05060434420787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown