BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 23140161 · Received September 24, 2025

    Report

    Report Number
    3016250252-2025-00008
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    June 11, 2025
    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

    REPORTED CONDITION: BIOMED OF FACILITY CALLED IN TO REPORT THAT MACHINE WAS MAKING A LOUD CLICKING NOISE BY THE BLOOD PUMP ROTOR. MACHINE INSTALLED 07/20/2022 MACHINE TOTAL RUN HOURS AT THE TIME OF EVENT WAS 7148HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597982 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other