BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 23140224 · Received September 25, 2025

    Report

    Report Number
    1056186-2025-00026
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 24, 2025
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED CONDITION: CUSTOMER REPORTED THAT SCREW FROM MISSING FROM BLOOD PUMP ROTOR AND ALARMING E075 BLOOD PUMP SPEED ERROR. MACHINE INSTALLED (B)(6) 2024, MACHINE TOTAL RUN HOURS AT THE TIME OF EVENT WAS 1689HRS. ACTION: NATIONAL SERVICE ENGINEER FOUND MISSING SCREW ON BLOOD PUMP ROTOR COVER AND PUSH PIN GAP AT 2MM. REPLACED FLAT HEAD SCREW ON ROTOR COVER. PUSH PIN CALIBRATED TO 0.2MM. MACHINE HEAT CITRIC DISINFECTED AND WORKING TO MANUFACTURER SPECIFICATIONS. READY FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851374 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other