BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 382588 · Received March 14, 2002

    Report

    Report Number
    1423500-2002-00334
    Event Type
    Death
    Date Received
    March 14, 2002
    Date of Event
    December 10, 2001
    Report Date
    February 19, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON RETURN OF THE HOMECHOICE CYCLER TO THE MANUFACTURING FACILITY, A NOTE WAS ATTACHED TO THE DEVICE WHICH STATES "SIRS, PLEASE GIVE THIS MACHINE A COMPLETE QC CHECK. PATIENT PASSED AWAY 2001 WHILE ON THIS MACHINE". FOLLOW UP WITH THE HOME PATIENT'S (HP) HEALTHCARE PROFESSIONAL (HCP) REVEALS THAT THE HP WAS USING THE HOMECHOICE CYCLER FOR APD THERAPY IN 2001. DURING THERAPY THE FAMILY MEMBER OF THE HP CALLED 911, DISCONNECTED THE HP FROM THE DISPOSABLE SETUP AND HAD THE HP TRANSPORTED TO THE HOSPITAL. HCP RELATES THAT THE HP WAS PRONOUNCED DECEASED AT THE HOSPITAL AND THE CAUSE OF DEATH WAS CARDIAC ARRYTHMIA. NO AUTOPSY WAS PERFORMED. ACCORDING TO THE HCP, THE HP HAD BEEN DIAGNOSED WITH TACHYCARDIA BEFORE THEIR DEATH AND HAD BEEN TAKING COUMADIN FOR IT, AS THEIR HEART RATE HAD INCREASED UP TO 140 BEATS PER MINUTE. HCP DOES NOT ATTRIBUTE THE HP'S DEATH TO BAXTER PRODUCTS BUT TO THE HP'S CO-MORBID CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED) HOMECHOICE FKX BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death