BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 23135087 · Received September 24, 2025

    Report

    Report Number
    3016250252-2025-00001
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    December 2, 2024
    Report Date
    September 24, 2025
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    PMA / PMN Number
    K182940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLOOD PUMP STOPPED IN THE MIDDLE OF THE PATIENT'S TREATMENT. THE MACHINE WAS ALARMING AND THEY WERE UNABLE TO PROCEED WITH THE TREATMENT AND UNABLE TO RETURN THE PATIENT'S BLOOD. THE CLINICAL TECHNICIAN FOUND A SCREW OR DESCRIBED AS A "BLACK RING" FALL OFF FROM THE PUMP. THE STAFF SAFELY MOVED THE PATIENT TO ANOTHER MACHINE AND WERE ABLE TO COMPLETE THE PATIENT'S TREATMENT. MACHINE INSTALLED (B)(6) 2023, MACHINE TOTAL RUN HOURS AT THE TIME OF EVENT WAS 2972HRS. SERVICE TECH VISITED THE FACILITY, REPLACED THE BLOOD PUMP ASSEMBLY. THEY CALIBRATED THE BLOOD PUMP OCCLUSION, AND THE PUMP SEGMENT PUSH PIN GAP. PERFORMED A SUCCESSFUL SIMULATED PATIENT TREATMENT WITH NO ALARMS OR ERRORS NOTED. PERFORMED HEAT DISINFECTION WITH CITRIC ACID. MACHINE IS OPERATING TO MANUFACTURER SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824597 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other