BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 23729340 · Received December 5, 2025

    Report

    Report Number
    3030306055-2025-00575
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 5, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G1: MANUFACTURING FACILITY - THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: (B)(6). 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 FROM AN UNSPECIFIED LOCATION OF A HOMECHOICE CASSETTE (OBSERVED AS FLUID IN THE GASKET AREA OF THE HOMECHOICE CLARIA DEVICE) WAS REPORTED, 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 CLARIA DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE HOME PATIENT (HP) DISCONNECTED DURING THE INITIAL DRAIN AND WAS NOT CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING SETUP FOR PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED DUE TO THE OBSERVATION THAT THE HOMECHOICE CLARIA ¿STARTED TO LEAK FLUID FROM THE GASKET¿ (CASSETTE DOOR) WHICH LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH CLEARING THE ALARM 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
    2884481 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CLARIA