BEUDAMED
    FDA Adverse Event Death Summary report: N

    AK 98 MACHINE

    MDR report key: 25279036 · Received May 26, 2026

    Report

    Report Number
    9616026-2026-00081
    Event Type
    Death
    Date Received
    May 26, 2026
    Date of Event
    April 18, 2026
    Report Date
    May 26, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT PASSED AWAY WHEN PREPARING TO START A DIALYSIS TREATMENT USING AN AK 98 MACHINE. PRIOR TO THE EVENT OF DEATH, IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO THE LINES AND THEN DISCONNECTED AGAIN. THE REASON WAS NOT REPORTED. IT WAS REPORTED THAT THE CUSTOMER DOES NOT BELIEVE THAT TREATMENT WAS INITIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351196 AK 98 MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1