BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 23139896 · Received September 24, 2025

    Report

    Report Number
    1056186-2025-00021
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    April 10, 2025
    Report Date
    September 24, 2025
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED CONDITION: BLOOD PUMP ROTOR MISSING SCREW AND WASHER. MACHINE INSTALLED (B)(6) 2024 MACHINE TOTAL RUN HOURS AT THE TIME OF EVENT WAS 792HRS. (B)(6) 2025: NATIONAL SERVICE ENGINEER REPLACED WITH A NEW BLOOD PUMP ASSEMBLY. MACHINE IS OPERATING TO MANUFACTURERS SPECIFICATIONS. READY FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597963 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other