BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 22583103 · Received July 23, 2025

    Report

    Report Number
    1416980-2025-03882
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 23, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER CITY: H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED. THIS WAS DESCRIBED AS THE ¿DIALYSIS BOX OF THE USER'S CALL FEEDBACK LINE IS LEAKING FROM INSIDE THE DEVICE'S VALVE". THIS OCCURRED DURING AN UNKNOWN PROCESS STEP OF AUTOMATED PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. 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
    1604957 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CLARIA