BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 4252068 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40731
    Event Type
    Death
    Date Received
    November 14, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED IN JULY 2013. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT OF DEATH. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED EVENT. A DEVICE HISTORY RECORD REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A ONE HOUR SIMULATED THERAPY WAS SUCCESSFULLY PERFORMED. THE DEVICE UNDERWENT FUNCTIONAL TESTING BUT WAS DETERMINED TO MEET PRODUCT SPECIFICATIONS RELATED TO THE REPORTED EVENT. DURING EVALUATION, NO FAILURE, MALFUNCTION, OR INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE CAUSE OF THE REPORTED EVENT OF DEATH COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST. THE PATIENT WAS NOT HOSPITALIZED PRIOR TO PASSING AWAY. IT WAS UNKNOWN IF PERITONEAL DIALYSIS THERAPY WAS ONGOING OR IF THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736652 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death