BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 24888051 · Received April 15, 2026

    Report

    Report Number
    9612057-2026-00048
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Report Date
    May 20, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    UDI-DI
    05413760005362
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: EXPIRATION DATE: ON 06/2030. E1: INITIAL REPORTER FACILITY NAME, ADDRESS, AND CITY: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK DEBRIS WAS OBSERVED WITHIN THE LINES OF THE HOMECHOICE AUTOMATED PD SET WITH CASSETTE. THE ISSUE WAS IDENTIFIED PRIOR TO DEVICE USE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317569 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA S25G23007 05413760005362

    Patients

    Seq Age Sex Outcome Treatment
    1