BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 381457 · Received March 4, 2002

    Report

    Report Number
    1423500-2002-00295
    Event Type
    Malfunction
    Date Received
    March 4, 2002
    Date of Event
    February 27, 2002
    Report Date
    February 27, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PT'S (HP) CARETAKER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER FOR ASSISTANCE DURING HP'S APD THERAPY. THE HP HAD ACCIDENTALLY DISCONNECTED SELF FROM THE PATIENT LINE OF THE HOMECHOICE CASSETTE. THE CARETAKER DISCONTINUED THERAPY AT THE TIME OF THE CALL AND RESUMED THERAPY WITH AN ENTIRELY NEW SET UP. FOLLOW UP WITH THE HP'S CARETAKER INDICATED THERAPY WAS COMPLETED AND NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 75 YR HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT.