BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3915708 · Received July 7, 2014

    Report

    Report Number
    1416980-2014-21647
    Event Type
    Death
    Date Received
    July 7, 2014
    Date of Event
    September 2, 2013
    Report Date
    June 12, 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). THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURE, MALFUNCTION OR IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED THAT DURING VISUAL INSPECTION FOUND NO BACKLIGHTS. THE KEYPAD LIGHTED CABLE WAS REPLACED FOR NO BACKLIGHTS. THE DEVICE PASSED ALL CHECK AND CALIBRATION TESTS SUCCESSFULLY DURING SERVICE. THE POWER ON SELF-TEST WAS SUCCESSFULLY COMPLETED. THE POWER ON SELF-TEST WAS SUCCESSFULLY COMPLETED. THE ONE HOUR THERAPY WAS COMPLETED WITHOUT ERROR OR ALARM. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. PER THE DEVICE EVALUATION, THERE WAS NO FAILURE, MALFUNCTION OR IIPV EVENT IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE OF PATIENT PASSING AWAY. THE CAUSE IS UNDETERMINED. 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. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED UNTIL OR UP TO THE TIME OF DEATH. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED AND IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393778 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death