BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 23245325 · Received October 8, 2025

    Report

    Report Number
    3030306055-2025-00375
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 8, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G1: THE DEVICE WAS MANUFACTURED AT ONE OF THE FOLLOWING FACILITIES: 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. 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 DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL TWO OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. THE SUPPLY BAG TO SUPPLY LINE WAS WET. RENAL THERAPY SERVICES (RTS) GUIDED THE PATIENT TO END THERAPY AND ADVISED THE PATIENT TO CONTACT THEIR NURSE REGARDING THE ISSUE. 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
    2610076 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CLARIA