BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4161973 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35276
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE WAS AN UNKNOWN DATE AND MONTH IN 2001. THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. A DEVICE HISTORY RECORD REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE HOME PATIENT PASSING AWAY. DURING VISUAL INSPECTION, THE UNIT COVER AND DOOR COVER WERE FOUND STAINED. THE UNIT AND DOOR COVER WERE REPLACED. THE POWER ON SELF-TEST WAS SUCCESSFULLY PERFORMED. A SHORT SIMULATED THERAPY WAS SUCCESSFULLY PERFORMED. THE DEVICE PASSED ALL CHECK AND CALIBRATION TESTS SUCCESSFULLY DURING SERVICE. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PATIENT¿S DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED OR IF THE PATIENT WAS PERFORMING PD THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644443 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O