BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM ROLLER PUMP - 6"

    MDR report key: 24519752 · Received March 5, 2026

    Report

    Report Number
    3006073153-2026-00047
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    March 8, 2023
    Report Date
    March 5, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    UDI-DI
    05060434420787
    PMA / PMN Number
    K173834
    Removal / Correction Number
    Z-0224-2025
    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

    INVESTIGATION CONFIRM THE LEFT SIDE BOBBINS ARE STRIPPED AND WOULD NOT STAY LOCKED. THIS EVENT WAS ORIGINALLY REPORTED IN A SUMMARY REPORT 3006073153-2025-00059, WHICH WAS SUBMITTED IN RELATION TO THE AFFECTED DEVICES FROM THE VOLUNTARY RECALLED PERFORMED BY SPECTRUM MEDICAL LTD (RECALL NUMBER Z-0224-2025). FDA HAS SINCE REQUESTED THAT EACH EVENT FOR THE DEVICES RELATED TO THE VOLUNTARY RECALL BE INDIVIDUALLY SUBMITTED, RESULTING IN THE CREATION AND SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 0

    USER REPORTED THAT WHEN BOBBIN LOCKED, RATCHETS WOULD NOT REMAIN LOCKED IN PLACE AND TUBING WAS NOT SECURED TIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583691 QUANTUM ROLLER PUMP - 6" ROLLER PUMP DTQ SPECTRUM MEDICAL LTD QRP6 05060434420787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown