BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AK 98 MACHINE

    MDR report key: 25262157 · Received May 22, 2026

    Report

    Report Number
    9616026-2026-00080
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    February 2, 2026
    Report Date
    May 22, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    UDI-DI
    7332414122966
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED; HOWEVER THE INVOLVED AK 98 MACHINE WAS EVALUATED ON SITE BY A VANTIVE QUALIFIED TECHNICAL SERVICE REPRESENTATIVE. THROUGH LOG FILE ANALYSIS, IT HAS BEEN ASCERTAINED THAT THE OPERATOR SET THE MACHINE TO PERFORM AN ISOLATED UF (ULTRAFILTRATION) TREATMENT. THE MACHINE CORRECTLY PERFORMED THE SESSION IN ISOLATED MODE. DURING THE MACHINE INSPECTION, NO ISSUE WAS IDENTIFIED. A SHORT SIMULATED THERAPY WAS SUCCESSFULLY PERFORMED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE OPERATED AS INTENDED. IT WAS DETERMINED THAT THE PATIENT CONSEQUENCES MAY HAVE BEEN CAUSED BY THE MACHINE BEING SET IN ISOLATED ULTRAFILTRATION MODE. THE AK 98 OPERATOR¿S MANUAL PROVIDES INSTRUCTIONS ON HOW TO PERFORM THE CORRECT SET OF TREATMENT PARAMETERS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A 4-HOUR RENAL REPLACEMENT THERAPY (RRT) USING AN AK 98 MACHINE. REPORTEDLY, AFTER THE 4 HOURS, IT WAS FOUND THAT THE DIALYSIS MACHINE REMAINED IN SELF-TEST MODE. THIS DID NOT TRIGGER A MALFUNCTION, AND THE THERAPY WAS NOT PERFORMED. TREATMENT WAS DISCONTINUED. IT WAS REPORTED THAT "CONDUCTION DISTURBANCES" OCCURRED 30 MINUTES AFTER THE END OF THE SESSION WITH "PERSISTENT HYPERKALEMIA (>7 MMOL/L)" IN ADDITION TO "BRADYCARDIA WITH LOW OUTPUT DURING PRE-CARDIAC ARREST MEDICAL TREATMENT, REQUIRING AN URGENT FOLLOW-UP DIALYSIS SESSION". NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130522 AK 98 MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA NA 7332414122966

    Patients

    Seq Age Sex Outcome Treatment
    1