BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 4040040 · Received August 27, 2014

    Report

    Report Number
    1416980-2014-28312
    Event Type
    Death
    Date Received
    August 27, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 5, 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). ADDITIONAL INFORMATION: THE INITIAL REPORTER DECLINED TO PROVIDE ADDITIONAL INFORMATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND INDICATED THAT MANUFACTURE OF THE DEVICE IS NOT RELATED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. A REVIEW OF THE DEVICE LOGS REVEALED THERE WAS NO FAILURE, MALFUNCTION, OR INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. A POWER ON SELF-TEST WAS SUCCESSFULLY PERFORMED AND THE DEVICE COMPLETED A ONE HOUR THERAPY WITH NO ISSUES NOTED. THE DEVICE PASSED ALL CHECK AND CALIBRATION TESTS SUCCESSFULLY. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. UPON CONCLUSION OF THE INVESTIGATION, NO FAILURES, MALFUNCTIONS, OR ABNORMALITIES WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH. 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 PRIOR TO OR AT THE TIME OF DEATH. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING PRIOR TO DEATH. IT WAS NOT REPORTED IF THE PATIENT WAS USING BAXTER PD SOLUTIONS OR BAXTER PD DEVICE(S) PRIOR TO PASSING AWAY OR AT 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
    522421 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death