BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 1230840 · Received November 17, 2008

    Report

    Report Number
    1423500-2007-00123
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 12, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INT'L AFFILIATE REPORTED LEAKAGE OF SOLUTION FROM THE CONNECTION BETWEEN THE HOMECHOICE CASSETTE AND THE MACHINE. THE HOMECHOICE MACHINE ALARMED AND MADE THE PATIENT AWARE OF THE LEAK. HE TRIED WITH THREE DIFFERENT UNITS (THE SAME BATCH) AND HE FOUND THE SAME ISSUE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA S06109055

    Patients

    Seq Age Sex Outcome Treatment
    1