BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 24152776 · Received January 22, 2026

    Report

    Report Number
    3038195011-2026-00095
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 22, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G1: MANUFACTURING FACILITY - THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: VANTIVE HEALTHCARE - MOUNTAIN HOME, 1900 N HIGHWAY 201, MOUNTAIN HOME, AR 72653, UNITED STATES. VANTIVE HEALTHCARE - DOMINICAN REPUBLIC, CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO, PIISA HAINA, SAN CRISTOBAL 91000, DOMINICAN REPUBLIC. 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 FROM THE PATIENT LINE. THIS OCCURRED DURING PREPARATION OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH REMOVING SUPPLIES AND GUIDED THE PATIENT TO START OVER WITH NEW SUPPLIES. 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
    209194 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CLARIA.