BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 23151831 · Received September 25, 2025

    Report

    Report Number
    3016250252-2025-00015
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    July 2, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED CONDITION: CUSTOMER REPORTED THAT ONE OF THE SCREWS CAME OFF OF THE BLOOD PUMP ROLLER MACHINE INSTALLED (B)(6) 2025, MACHINE RUN HOURS AT TIME OF EVENT 364HRS. (B)(6) 2025 THE NATIONAL SERVICE ENGINEER IDENTIFIED THAT ONE OF THE SCREWS THAT'S USED TO ADJUST THE ROLLER GAP ON THE BLOOD PUMP ROTOR WAS MISSING. ALSO IDENTIFIED THAT THE SCREW WAS RUBBING AGAINST THE BLOOD PUMP HOUSING NOW ALLOWING THE ROTOR TO MOVE FREELY. INSPECTED THE INNER AND OUTER COMPONENTS OF THE BLOOD PUMP AND IDENTIFIED THE MISSING SCREW ON THE BLOOD PUMP ROTOR, NO OTHER ISSUES IDENTIFIED. INSTALLED A NEW BLOOD PUMP ROTOR AND PERFORMED THE BLOOD PUMP OCCLUSION CALIBRATION TO MANUFACTURE SPECIFICATIONS. RAN A SIMULATED TREATMENT WITH NO ISSUES OR ALARMS DURING TESTING. DEVICE HAS BEEN TESTED, VERIFIED, AND DISINFECTED PER IFU. SDX IS OPERATING TO MANUFACTURE SPECIFICATIONS AND RELEASED FOR PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060037 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other