BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 656844 · Received December 23, 2005

    Report

    Report Number
    1423500-2005-02088
    Event Type
    Malfunction
    Date Received
    December 23, 2005
    Date of Event
    November 1, 2005
    Report Date
    December 1, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTED A CRACKED CASSETTE FOUND DURING THE PRIMING CYCLE. NO PT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF 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 FKK BAXTER HEALTHCARE CORPORATION NA SE05EM4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN