BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 25001032 · Received April 27, 2026

    Report

    Report Number
    3016250252-2025-00021
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    November 7, 2025
    Report Date
    April 27, 2026
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    UDI-DI
    00383790008815
    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: LOOSE SCREW ON BLOOD PUMP ROTORS ON BOTH MACHINES REPORTED BY STAFF ON B)(6): EXISTING BLOOD PUMP ROTOR REQUIRES REPLACEMENT. SCREWS ON FACE PLATE ARE LOOSE. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY AND PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. THE MACHINE OPERATES PER THE MANUFACTURER SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216167 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01 00383790008815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other