BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 23147679 · Received September 25, 2025

    Report

    Report Number
    3016250252-2025-00010
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 25, 2025
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    PMA / PMN Number
    K182940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED CONDITION: BLOOD PUMP ROTOR ASSEMBLY WAS MISSING A NUT THAT IS ATTACHED TO A SCREW INSIDE THE BLOOD PUMP. MACHINE INSTALLED ON (B)(6) 2025, MACHINE TOTAL RUN HOURS AT THE TIME OF EVENT WAS 1149HRS. ON (B)(6) 2025: THE NATIONAL ENGINEER CONFIRMED THAT THE NUT WAS MISSING AND REPLACED THE ROTOR ASSEMBLY. PREPARATION WAS COMPLETED AND RAN IN TREATMENT MODE NO ALARMS OCCURRED. THE MACHINE WAS HEAT DISINFECTED, AND IT OPERATES ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2738233 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other