BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM ROLLER PUMP - 6"

    MDR report key: 24950249 · Received April 22, 2026

    Report

    Report Number
    3006073153-2026-00114
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 22, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    UDI-DI
    05060434420787
    PMA / PMN Number
    K173834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONFIRMED MULTIPLE FET TEMPERATURE WARNINGS FROM DEVICE HISTORY LOGS, SUGGESTING A DAMAGED FET OR THERMISTOR ON AN FET.

    Description of Event or Problem · 0

    USER REPORTED A ROLLER PUMP HARDWARE FAILURE DURING THE PROCEDURE, WHICH RESULTED IN PUMP REPLACEMENT. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014506 QUANTUM ROLLER PUMP - 6" CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SPECTRUM MEDICAL LTD QRP6 05060434420787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown