BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MPS DELIVERY SET

    MDR report key: 23866169 · Received December 22, 2025

    Report

    Report Number
    1649914-2025-00027
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 22, 2025
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    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

    THIS COMPLAINT (B)(4) IS A REPORT OF THE BLOOD LEAKING OUT TO ATMOSPHERE FROM THE CHECK VALVE TO HEX LUER LOCATION. (B)(4) HAS THE SAME FAILURE MODE AS CC25--494, --495, AND --516. LINKED TO 1649914-2025-00024 (MDR25-00024) SUPPLEMENTAL SUBMISSIONS. NO SAMPLE WAS RECEIVED FOR ANALYSIS AND THUS INVESTIGATION OF THE SAMPLES COULD NOT BE COMPLETED. A PROCESS REVIEW WAS COMPLETED OF THE DRUG DELIVERY LINE ASSEMBLY, AND NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE CHECK VALVE IS MANUFACTURED AT AN EXTERNAL SUPPLIER. THE CAUSE OF THE FAILURE CANNOT BE TRACED TO QUEST MANUFACTURING PROCESS. THE ROOT CAUSE OF THE CHECK VALVE LEAK IS BEING INVESTIGATED IN SUPPLIER CORRECTIVE ACTION REPORT. THE INFORMATION GENERATED AND/OR DATA ACCUMULATED DURING THIS INVESTIGATION WILL BE FILED FOR FUTURE REFERENCE. WE WILL CONTINUE TO MONITOR AND TREND ANY PROBLEMS ASSOCIATED WITH THIS DEVICE AS WE STRIVE TO CONTINUOUSLY IMPROVE OUR PRODUCTS.

    Description of Event or Problem · 0

    ON 12/02/2025, A USER AT SAN ANTONIO REGIONAL HOSPITAL IN UPLAND, CALIFORNIA REPORTED A MALFUNCTION REGARDING PRODUCT 5161102, LOT NUMBER 77324.THE REPORT STATES BLOOD DID NOT MAKE IT TO THE POUCH BUT DID ALARM WITH THE SAME ERROR BEFORE PRIMING SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210619 MPS DELIVERY SET MYOCARDIAL PROTECTION SYSTEM DTR QUEST MEDICAL, INC. 5161102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other