BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3930113 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22391
    Event Type
    Death
    Date Received
    July 11, 2014
    Report Date
    June 17, 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). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 WILL BE SUBMITTED. A DEVICE HISTORY REVIEW REVEALED THE DEVICE THERE ARE NO NONCONFORMITIES, REWORK ACTIVITIES, OR FIRST PASS TEST SPECIFICATION FAILURES RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING OR IF THE PATIENT WAS CONNECTED TO THE HC 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
    407782 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death