BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    QUANTUM ROLLER PUMP 6"

    MDR report key: 21282907 · Received January 31, 2025

    Report

    Report Number
    3006073153-2025-00044
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Report Date
    January 31, 2025
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    UDI-DI
    05060434420787
    PMA / PMN Number
    K173834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION: (B)(4) - FOUND THAT A LID MISS MATCH ERROR OCCURRED CAUSING THE PUMP TO STOP. THIS OCCURS WHEN THE MAGNET IN THE LID OF THE PUMP DOES NOT MATCH UP WITH THE MAGNET IN THE PUMP. USER ARE TRAINED TO OVERRIDE THIS ERROR IN CASES WHEN THIS OCCURS. (B)(4) - INVESTIGATION FOUND A CABLE WITHIN THE PUMP WAS DAMAGED. THE CABLE WAS REPLACED, AND THE PUMP FUNCTIONED AS EXPECTED FROM THAT POINT ONWARDS. (B)(4) - INVESTIGATION FOUND A FAULTY PIN ON THE ENCODER WITHIN THE PUMP WAS DAMAGED. THE ENCODER WAS REPLACED, AND THE PUMP FUNCTIONED AS EXPECTED FROM THAT POINT ONWARDS. PLEASE FIND ATTACHED A SPREADSHEET LISTING THE SERIAL NUMBERS OF THE DEVICES SUMMARISED IN THIS SUMMARY REPORT.

    Description of Event or Problem · 0

    USERS REPORTED EXPERIENCING PUMP STOP DURING A CASE. IN THESE CASES, THERE WAS NO PATIENT HARM. SPECTRUM MEDICAL CONSIDERS INTERRUPTION TO BLOOD FLOW A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494922 QUANTUM ROLLER PUMP 6" ROLLER PUMP DTQ SPECTRUM MEDICAL LTD QRP6 05060434420787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown