BEUDAMED
    FDA Adverse Event Death Summary report: N

    AK 98 MACHINES

    MDR report key: 22894663 · Received August 26, 2025

    Report

    Report Number
    9616026-2025-00063
    Event Type
    Death
    Date Received
    August 26, 2025
    Date of Event
    August 2, 2025
    Report Date
    September 23, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: THE DEVICE WAS NOT RECEIVED FOR EVALUATION. THE COMPLAINTS AND SERVICE HISTORY REVIEW REVEALED NO SIMILAR EVENTS OCCURRED ON THIS MACHINE. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS NO FURTHER DETAILS WERE PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING HEMODIALYSIS WITH AN AK 98 MACHINE, THE PATIENT PASSED AWAY. THE CAUSE OF THE DEATH WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS "RECEIVING DIALYSIS" AT THE TIME OF DEATH IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE REPORTER STATED THAT "THIS WAS NOT AN UNEXPECTED DEATH AND MADE NO CLAIM AGAINST THE PRODUCT". THE REPORTER DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866388 AK 98 MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death