BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 23151263 · Received September 25, 2025

    Report

    Report Number
    1056186-2025-00028
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 25, 2025
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED CONDITION: SCREW MISSING FROM THE BLOOD PUMP ROTOR FACE PLATE. MACHINE INSTALLED (B)(6) 2024, MACHINE RUN HOURS AT TIME OF EVENT 2580HRS. (B)(6) 2025: NEW BLOOD PUMP ROTOR WAS INSTALLED AND TESTED BY THE NATIONAL SERVICE ENGINEER. MACHINE IS OPERATING TO MANUFACTURERS SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302674 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other