BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1193169 · Received October 7, 2008

    Report

    Report Number
    1423500-2008-00858
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PATIENT CONTACTED BAXTER REGARDING THE TUBING ON A HOMECHOICE CASSETTE BEING RIPPED ABOUT AN INCH AWAY FROM THE CASSETTE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX BAXTER HEALTHCARE CORPORATION H08F26111

    Patients

    Seq Age Sex Outcome Treatment
    1