BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3892862 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20179
    Event Type
    Death
    Date Received
    June 24, 2014
    Report Date
    May 30, 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). A SERVICE HISTORY REVIEW SHOWED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY. IN ADDITION, THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE WAS RETURNED AND EVALUATED. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE PATIENT DEATH. THE DEVICE UNDERWENT AN EXTERNAL AND INTERNAL INSPECTION WHICH IDENTIFIED UNRELATED ISSUES: DOOR COVER WAS FOUND DAMAGED AND UNIT HAD NO INNER DOOR GASKET AND BACKLIGHT. THE ONE HOUR SIMULATED THERAPY WAS NOT SUCCESSFULLY PERFORMED DUE TO THERE BEING NO INNER DOOR GASKET. AS A RESULT, THE DOOR COVER WAS REPLACED, THE INNER DOOR GASKET WAS INSTALLED AND THE KEYPAD LIGHTED CABLE WAS REPLACED. THE DEVICE WAS REPAIRED ACCORDING TO REQUIRED PROCEDURES AND IT PASSED ALL CHECK AND CALIBRATION TESTS SUCCESSFULLY DURING SERVICE. THE DEVICE WAS THEN RETURNED TO THE LOANER POOL IN GOOD WORKING CONDITION. THE REPORTED DEATH COULD NOT BE VERIFIED THROUGH THE DEVICE EVALUATION. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR 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

    THIS IS A REPORT OF A PATIENT WHO PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE MACHINE. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368558 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death