BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIPRO SURDIAL DX HEMODIALYSIS SYSTEM

    MDR report key: 25340479 · Received May 29, 2026

    Report

    Report Number
    1056186-2026-00027
    Event Type
    Death
    Date Received
    May 29, 2026
    Date of Event
    February 20, 2026
    Report Date
    May 29, 2026
    Manufacturer
    SHIBUYA (SBY)
    Product Code
    KDI
    UDI-DI
    00383790008815
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER CONTACTED OUR SERVICING HOTLINE REQUESTING SERVICING FOR 2 MACHINES AND THEN PROCEEDED TO REPORT ANOTHER MACHINE THAT WAS SEQUESTERED DUE TO PATIENT TREATMENT EVENT WHERE THE PATIENT CODED DURING TREATMENT AND WAS HOSPITALIZED, SUBSEQUENTLY REPORTING THE PATIENT PASSED AWAY. CUSTOMER DECLINED TO SHARE ANY ADDITIONAL INFORMATION DUE TO COMPANY POLICY AND PROCEDURES. THE FACILITY ADMINISTRATOR STATED THAT THEY DO NOT BELIEVE OUR MACHINE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527675 NIPRO SURDIAL DX HEMODIALYSIS SYSTEM DIALYSIS MACHINE KDI SHIBUYA (SBY) MC+SDX01 00383790008815

    Patients

    Seq Age Sex Outcome Treatment
    1