BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH LINEO CONNECTOR 4-PRONG

    MDR report key: 541410 · Received March 24, 2004

    Report

    Report Number
    1423500-2004-00260
    Event Type
    Malfunction
    Date Received
    March 24, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 10, 2003
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Removal / Correction Number
    1423500-12/5/03-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTED THE FOLLOWING: IT HAS DISCONNECTED TWICE. THE PT WAS INSTRUCTED TO TAPE THE CONNECTION. WHEN DOING 'WEEK 1' ASSESSMENT ON PT THEY CONFESSED THEY HAD TWO DISCONNETIONS FROM THE CYCLER. THE MACHINE FILLED WITH AIR SINCE THE DISCONNECTION OCCURRED ON DRAIN. THEY WERE INSTRUCTED BY ANOTHER CO TO RESET THEIR MACHINE OR USE THE TWIN BAGS. NO PT INJURY OR MEDICAL INTERVENTION WAS INDICATED BY BAXTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH LINEO CONNECTOR 4-PRONG HOMECHOICE CASSETTE KDJ BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR