BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 23534930 · Received November 12, 2025

    Report

    Report Number
    9612057-2025-00133
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Report Date
    December 10, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    UDI-DI
    00085412040516
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3/D10: THE EVENTS OCCURRED ON AN UNSPECIFIED DATE IN OCTOBER 2025. E1: INITIAL REPORTER ADDRESS: (B)(6). H11: THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H3, H6, AND H11: H11: FOUR (4) ACTUAL DEVICES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND SEPARATED SHEETING WAS OBSERVED IN ALL FOUR SAMPLES. UNDER WATER PRESSURE TESTING WAS PERFORMED AND A LEAK WAS OBSERVED AT THE SEPARATED SHEETING LOCATION. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE DAMAGE WAS DUE TO A WELDING ISSUE DURING MANUFACTURING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ¿TRANSPARENT PLATE¿ OF FOUR (4) HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTES WERE TORN WHICH RESULTED IN A LEAK. FURTHER DESCRIBED AS ¿A LEAK OCCURRED IN THE SQUARE TRANSPARENT PLATE CONNECTED TO THE CLARIA MACHINE¿. THIS WAS OBSERVED AFTER INSTALLING THE DEVICES IN THE HOMECHOICE CLARIA MACHINE FOR USE IN PERITONEAL DIALYSIS.THE CASSETTE SETS WERE REPLACED AND THERAPY WAS STARTED. 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
    403854 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA S25B17007 00085412040516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male HOMECHOICE CLARIA