BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO AUTOMATED PD SYSTEM 115 VOLT

    MDR report key: 633289 · Received September 1, 2005

    Report

    Report Number
    1423500-2005-01394
    Event Type
    Death
    Date Received
    September 1, 2005
    Date of Event
    August 4, 2005
    Report Date
    August 4, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION LARGO
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CORONER STATED THAT THE PT HAD BEEN FOUND DEAD AT HOME WHILE STILL CONNECTED TO THE HOMECHOICE PRO AUTOMATED PD SYSTEM. THE HOMECHOICE PRO AUTOMATED PD SYSTEM DISPLAYED SHOWED "END OF THERAPY". THE HOME PT WAS STILL CONNECTED TO THE HOMECHOICE PRO AUTOMATED PD SYSTEM WHEN THE CORONER ARRIVED. THE CORONER STATED THAT THE HOME PT MAY HAVE BEEN DEAD OVER 24 HRS. BAXTER TECHNICAL SERVICE EXPLAINED THE PROCEDURE FOR DISCONNECTING THE PT FROM THE HOMECHOICE PRO AUTOMATED PD SYSTEM. THE CORONER STATED THAT IT LOOKED LIKE A ROUTINE CASE. RN AT THE DIALYSIS CENTER STATED THAT THE PT HAD DIED IN THE NIGHT. THE PT HAD A HEART TRANSPLANT 15-20 YEARS AGO. THE PT HAS BEEN ON PD APPROX ONE YEAR. THE PT HAD A HABIT OF NOT CALLING ANYONE WHEN NOT FEELING WELL. THE DIALYSIS CENTER WOULD BY CHANCE FIND OUT INFORMATION LATER ON. THE PT WAS SUPPOSED TO COME IN FOR A LAB DRAW IN 08/2005 BUT DID NOT COME IN. THEREFORE THE NURSE WAS GOING TO CALL THE HOME PT NEXT DAY FOR A WELLNESS CALL. THE CORONER'S OFFICE CALLED TO TELL HER OF THE PT'S DEATH ON THE SAME DAY. THE HOMECHOICE PRO AUTOMATED PD SYSTEM HAS A DATA CARD CALLED A PRO CARD. THE PRO CARD HAD NOT BEEN INSERTED PROPERLY. THEREFORE THE NURSE WAS NOT ABLE TO GET THE ACTUAL VS. PRESCRIBED INFORMATION FOR THE DATES PRIOR TO THE PT'S DEATH FROM THE PRO CARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO AUTOMATED PD SYSTEM 115 VOLT HOME CHOICE PRO FKX BAXTER HEALTHCARE CORPORATION LARGO NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death