BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3760368 · Received April 20, 2014

    Report

    Report Number
    1416980-2014-12709
    Event Type
    Death
    Date Received
    April 20, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 25, 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). A SERVICE HISTORY RECORD/DEVICE HISTORY RECORD REVIEW WILL BE PERFORMED. SHOULD ANY RELEVANT INFORMATION BE OBTAINED FROM THIS REVIEW THAT IS RELATED TO THE REPORTED EVENT OR THROUGH OTHER MEANS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOME CHOICE DEVICE WAS RETURNED AND EVALUATED, ALL FUNCTIONAL TESTS WERE PERFORMED. A VISUAL INSPECTION FOUND NO PHYSICAL DAMAGE. THE POWER ON SELF-TEST WAS SUCCESSFULLY COMPLETED. EVENT HISTORY WAS DOWNLOADED AND THERE WERE NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT WOULD INDICATE AND/OR CONTRIBUTE TO THE PROBLEM. THE ONE HOUR THERAPY WAS COMPLETED WITHOUT ERROR OR ALARM. THE DEVICE PASSED ALL CHECK AND CALIBRATION TESTS SUCCESSFULLY. THE ONE HOUR THERAPY WAS COMPLETED WITHOUT ERROR OR ALARM. THE DIGITAL BOARD WAS REPLACED AS A PREVENTIVE ACTION. REVIEW OF THE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE PERITONEAL DIALYSIS (PD) PATIENT WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. PRIOR TO DEATH, THE PATIENT WAS PLACED IN PALLIATIVE CARE AND THE CONDITIONED WORSENED. WHILE IN PALLIATIVE CARE THE PATIENT WAS RECEIVING UNSPECIFIED PAIN MEDICATION. IT WAS REPORTED THAT PD THERAPY WAS DISCONTINUED FOR "OVER A WEEK" PRIOR TO THE EVENT OF DEATH. THE CAUSE OF DEATH WAS REPORTED TO BE WITHDRAWAL FROM DIALYSIS; THEREFORE, THE HOMECHOICE PRO IS NO LONGER CONSIDERED SUSPECT PRODUCT IN THIS EVENT. A DEVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. 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 (PD) PATIENT (PT) WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY DUE TO AN UNKNOWN CAUSE. THE PT WAS NOT PERFORMING PD THERAPY AT THE TIME OF DEATH. 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
    239202 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death