BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 721632 · Received May 25, 2006

    Report

    Report Number
    1423500-2006-00634
    Event Type
    Malfunction
    Date Received
    May 25, 2006
    Date of Event
    March 31, 2006
    Report Date
    March 31, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTED A LEAK DURING USE OF THE HOMECHOICE CASSETTE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF HTE 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 H05J13115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN