BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS2 CONSOLE

    MDR report key: 21337838 · Received February 7, 2025

    Report

    Report Number
    1649914-2025-00002
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 31, 2025
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K173716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED AND THE ALLEGED ISSUE COULD NOT BE DUPLICATED. A LOOSE CAM BELT AND NOISE IN HEX BLOCK WAS OBSERVED. THE O-RING HEX BLOCK AND PUCK SEALS WERE REPLACED AND THE DEVICE SUCCESSFULLY PASSED OPERATIONAL VERIFICATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUES COULD NOT BE ESTABLISHED. QUEST MEDICAL WILL CONTINUE TO MONITOR COMPLAINTS FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REPORT RECEIVED STATES THAT THE DEVICE WAS GIVING ERROR CODES. THE 10 MOST RECENT ERROR CODES WERE 213, 291, 213, 152, 212, 291, 213, 212, 152, AND 213. THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638168 MPS2 CONSOLE CARDIOPULMONARY BYPASS HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5201260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown