BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGRATED APD SET

    MDR report key: 24896212 · Received April 16, 2026

    Report

    Report Number
    3038195011-2026-00385
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 16, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    UDI-DI
    00085412090078
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. ECM - BAXTER HEALTHCARE ¿ HAINA. PIISA INDUSTRIAL PARK ANTIGUA, CARRETERA SANCHEZ KM 18 ½, 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 THE PATIENT LINE OF A HOMECHOICE CASSETTE ¿POPPED OFF.¿. THIS OCCURRED DURING SETUP OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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
    965923 INTERGRATED APD SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA ASKU 00085412090078

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male