BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOME CHOICE PRO

    MDR report key: 2379361 · Received December 12, 2011

    Report

    Report Number
    MW5023438
    Event Type
    Injury
    Date Received
    December 12, 2011
    Date of Event
    December 8, 2011
    Report Date
    December 12, 2011
    Manufacturer
    BAXTER HEALTH CARE CORP
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE A HOME CHOICE PRO AUTOMATIC PD SYSTEM PROVIDED BY BAXTER HEALTH CARE CORP. RECENTLY THE FDA REQUIRED THEM TO CHANGE THEIR SOFTWARE PROGRAM TO PREVENT BYPASSING THE INITIAL DRAIN AND ALL OTHER DRAINS. DUE TO THIS CHANGE THE PT NOW MUST SUFFER THROUGH A PAINFUL PERIOD CAUSED BY THE MACHINE TRYING TO SUCK FLUID FROM THE PERITONEAL CAVITY WHEN NONE EXISTS. ACCORDING TO BAXTER THE MACHINE SHOULD ALARM AND ALLOW FOR A BYPASS BUT THIS DOES NOT HAPPEN THUS THE PT REMAINS IN EXTREME PAIN FOR SEVERAL MINUTES DURING THE BEGINNING OF THE PD CYCLE. BAXTER OR SOMEONE NEEDS TO REEVALUATE THIS SOFTWARE CHANGE AND NOT EXPERIMENT WITH THE PT IN A HOME ATMOSPHERE. THIS CHANGE IN THE SOFTWARE ALSO CAUSES THE MACHINE TO NOT PROVIDE THE PROPER THERAPY, BY TAKING AWAY COMPLETE CYCLES OF EXCHANGING FLUIDS. I CAN UNDERSTAND THE NEED FOR PREVENTING OVER FILLING, BUT NOT IN THE WAY BAXTER HAS TRIED TO ACHIEVE THIS, THEN THERE ONLY RESPONSE IS THAT THE FDA HAS REQUIRED THE CHANGE. CHANGE IS GOOD BUT IT MUST BE PROVEN CHANGE AND NOT AN EXPERIMENTAL PROGRAM TRIED ON THE AT HOME PATIENT. DIAGNOSIS OR REASON FOR USE: ESRD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME CHOICE PRO AUTOMATED PD SYSTEM FKX BAXTER HEALTH CARE CORP HOME CHOICE PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other PERITONEAL DIALYSIS DONE EACH NIGHT FOR 8 HOURS