BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT

    MDR report key: 669819 · Received September 7, 2005

    Report

    Report Number
    1423500-2005-01396
    Event Type
    Malfunction
    Date Received
    September 7, 2005
    Date of Event
    August 3, 2005
    Report Date
    August 3, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HOME PT'S SPOUSE CONTACTED THE CUSTOMER SERVICE CENTER TO REPORT ABDOMINAL DISCOMFORT DURING DWELL PERIOD 3 OF 5. THE SERVICE REP PLACED THE HOME PT INTO A MANUAL DRAIN. THE PT STATED THAT THE NURSE HAD TOLD HER TO BYPASS THE INITIAL DRAIN (MDV=2030 ML). THE SERVICE REP PLACED THE HOME PT BACK INTO DWELL 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT PERSONAL CYCLER AUTOMATED PD SYSTEM FKX BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN