BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS 3 MYOCARDIAL PROTECTION SYSTEM

    MDR report key: 24390617 · Received February 19, 2026

    Report

    Report Number
    1649914-2026-00007
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 19, 2026
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K201984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE FINAL INVESTIGATION RESULTS FOR THE PREVIOUSLY REPORTED EVENT INVOLVING ERROR CODE 179 ON AN MPS 3 MYOCARDIAL PROTECTION SYSTEM (MODEL 5201260, SERIAL (B)(6). THE DEVICE WAS RETURNED AND INVESTIGATED. LOG DATA CONFIRMED ERROR CODES 179, 185, AND 189. THE CABLE CAM MOTOR WAS FOUND TO BE BURNT AND WAS REPLACED. ADDITIONALLY, AS PART OF A PREVIOUSLY INITIATED DESIGN CHANGE, RESISTORS R195, R175, R190, AND R193 ON THE MOTOR DRIVER PCA WERE CHANGED FROM 619OHMTO 430OHM TO ATTENUATE THE MOTOR DRIVE SIGNAL. ROOT CAUSE WAS DETERMINED TO BE A HEAT STRESSED MOTOR DUE TO THE ORIGINAL RESISTOR VALUES. NO PATIENT OR USER ADVERSE EVENT OCCURRED. THE DEVICE PASSED POST REPAIR FUNCTIONAL TESTING. NO FURTHER REMEDIAL ACTION IS REQUIRED FOR THIS UNIT. A QUALITY ALERT IS NOT WARRANTED.

    Description of Event or Problem · 0

    REPORT STATES CUSTOMER CALLED THE HOT LINE TO REPORT A COMPLAINT: ERROR CODE 179.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335596 MPS 3 MYOCARDIAL PROTECTION SYSTEM CARDIOPULMONARY BYPASS HEAT EXCHANGER, PRODUCT CODE: DTR, PRODUCT CODE: DTR 3. M DTR QUEST MEDICAL, INC. 5201260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown