BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD SET WITH CASSETTE

    MDR report key: 25046129 · Received April 30, 2026

    Report

    Report Number
    2314912-2026-00265
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Report Date
    April 30, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKK
    UDI-DI
    00085412153186
    PMA / PMN Number
    K151525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY, STATED AS "AROUND SEVEN (7)" UNITS, OF AMIA CASSETTE SETS WERE FOUND, TO BE "BROKEN" AT UNSPECIFIED LOCATIONS. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES 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
    59884 AMIA AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKK VANTIVE US HEALTHCARE LLC NA H26A06096 00085412153186

    Patients

    Seq Age Sex Outcome Treatment
    1