BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 191559 · Received October 9, 1998

    Report

    Report Number
    1423500-1998-01762
    Event Type
    Malfunction
    Date Received
    October 9, 1998
    Date of Event
    September 1, 1998
    Report Date
    September 24, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    BAXTER SVC CTR REPORTS LEK IN CASSETTE OF HOMECHOICE SET USED FOR AUTOMATED PERITONEAL DIALYSIS THERAPY. LEAK WAS IDENTIFIED BY SVC CTR WHEN MOISTURE WAS NOTED IN PNEUMATIC AREA OF RETURNED HOMECHOICE DEVICE. NO PT INJURY WAS REPORTED AT TIME OF DEVICE RETURN.

    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 CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN