BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 507120 · Received January 16, 2004

    Report

    Report Number
    1423500-2004-00048
    Event Type
    Death
    Date Received
    January 16, 2004
    Date of Event
    December 18, 2003
    Report Date
    December 18, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) OF THE HOME PT (HP) REPORTED THE HP EXPIRED WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. THE HCP RELATED THAT THE HP'S SPOUSE REPORTED THERE WERE NO DIFFICULTIES DURING APD THERAPY; THE HP WAS SLEEPING AFTER THE START OF APD THERAPY AND THERE WERE NO SYSTEM ALARMS. AT APPROX 3:30AM, THE HP'S SPOUSE REPORTEDLY WENT TO SAY GOODNIGHT TO THE HP AND FOUND HP HAD EXPIRED. THE HCP RELATED THAT THE HP'S SPOUSE NOTIFIED THE DIALYSIS FACILITY LATER THAT MORNING AND DISCONNECTED THE HP FROM THE HOMECHOICE SYSTEM. FOLLOW-UP WITH THE DIALYSIS FACILITY INDICATED THAT AN AUTOPSY WAS ANTICIPATED, HOWEVER, RESULTS HAVE NOT YET BEEN RECEIVED. HEALTHCARE PROFESSIONAL (HCP) HAS INDICATED THE HP HAD A HEART BLOCK, PACEMAKER AND IS IN NEED OF A HEART TRANSPLANT BUT HAS AN EJECTION FRACTION OF 10-15%.

    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 64 YR Death HOMECHOICE APD SET WITH CASSETTE 4-PRONG, 2003,| DIANEAL LOW CALCIUM SOLUTION 2.5%, 2003,| 12 FT. EXTENSION SET, 2003.| DIANEAL LOW CALCIUM SOLUTION 1.5%, 2003,