BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AK 96 MACHINES

    MDR report key: 15224667 · Received August 15, 2022

    Report

    Report Number
    9616026-2022-00078
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    June 20, 2022
    Report Date
    September 8, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS EVALUATED ON SITE BY A HOSPITAL TECHNICIAN. UPON VISUAL INSPECTION IT WAS FOUND THAT THE BYPASS SILICONE CONNECTOR WAS DISENGAGED WHICH LED TO A FLUID LEAKAGE AND EXCESSIVE FLUID REMOVAL. THE REPORTED CONDITION WAS VERIFIED. THE SILICONE CONNECTOR WAS REPLACED AND RECONNECTED, AND THE DEVICE WAS RETURNED BACK TO SERVICE WITH NO ISSUES NOTED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITHIN SIX MINUTES OF TREATMENT WITH AN AK 96 MACHINE, THE PATIENT ¿APPEARED HYPOTENSIVE¿ WITH A FLUID REMOVAL OF 4 KG. THE ULTRAFILTRATION VOLUME WAS SET AT 3300 ML AND THE DIALYSATE FLOW SET TO 500ML/MIN, TO REACH A TARGET WEIGHT OF 67 KG. AT COMPLETION OF FOUR HOURS OF TREATMENT. NO ALARM WAS GENERATED AT THE TIME OF THE EVENT, HOWEVER THE MACHINE GENERATED AN ALARM ¿P SDT 048 002¿ DURING PRIMING. IT WAS FURTHER REPORTED A LEAK FROM THE CONNECTOR WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348345 AK 96 MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male