BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 1230732 · Received November 17, 2008

    Report

    Report Number
    1423500-2007-00106
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    January 25, 2007
    Report Date
    January 25, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INT'L AFFILIATE REPORTED A LEAK IN THE TUBING. 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 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1