BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3800692 · Received May 8, 2014

    Report

    Report Number
    1416980-2014-14838
    Event Type
    Death
    Date Received
    May 8, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE LOGS REVEALED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT WOULD INDICATE AND/OR CONTRIBUTE TO THE REPORTED EVENT. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTIONS WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. A VISUAL INSPECTION WAS PERFORMED, NO ISSUES WERE FOUND. THE POWER ON SELF-TEST WAS SUCCESSFULLY PERFORMED. A ONE HOUR SIMULATED THERAPY WAS SUCCESSFULLY PERFORMED. THE DEVICE PASSED ALL CHECK AND CALIBRATION TESTS SUCCESSFULLY DURING SERVICE. THE DEVICE WAS SERVICED MORE THAN ONE YEAR AGO THEREFORE A SERVICE HISTORY REVIEW WILL NOT BE PERFORMED. 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 THERAPY FOR PERITONEAL DIALYSIS. IT WAS NOT REPORTED IF THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278764 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death