BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 23183804 · Received September 30, 2025

    Report

    Report Number
    3030306055-2025-00332
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 30, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. H11: AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS REPORTED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, A LEAK WAS REPORTED ON ONE OF THE LINES OF THE CASSETTE, WHICH IS KNOWN TO CAUSE THIS ALARM. THE CAUSE OF THE LEAK COULD NOT BE DETERMINED. 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 THREE OF FOUR OF PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK ON ONE OF THE LINES OF THE CASSETTE THAT LED TO THIS ALARM. RENAL THERAPY SERVICES ASSISTED THE CAREGIVER TO REMOVE THE SUPPLIES FROM THE THERAPY SESSION. 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
    2216129 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CLARIA