BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 23139777 · Received September 24, 2025

    Report

    Report Number
    3016250252-2025-00003
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    January 4, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED CONDITION: PARTS FELL OUT OF THE BLOOD PUMP. UPON ARRIVAL THE NATIONAL SERVICE ENGINEER CONFIRMED THAT PARTS HAD FALLEN OUT OF THE BLOOD PUMP. MACHINE INSTALLED 08/05/2024 MACHINE TOTAL RUN HOURS AT THE TIME OF EVENT WAS 913HRS ON 01/04/2024: NATIONAL SERVICE ENGINEER FOUND REPLACED WITH A NEW BLOOD PUMP. THEN BLOOD PUMP OCCLUSION, BLOOD PUMP ROLLER PRESSURE AND PUSH PIN GAP WAS VERIFIED TO BE IN SPEC. SIMULATED PATIENT TREATMENT, AND CITRIC HEAT DISINFECTION COMPLETED. MACHINE IS OPERATING TO MANUFACTURERS SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394092 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other