BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3973672 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25114
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE WITH THIS SERIAL NUMBER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. A VISUAL INSPECTION DID NOT FIND ANYTHING RELATED TO THE REPORTED EVENT. FUNCTIONAL TESTING WAS PERFORMED ON THE DEVICE. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED THE DEVICE WAS DETERMINED TO MEET SPECIFICATION REQUIREMENTS FOR THE REPORTED ISSUE. 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 DEATH COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). IT WAS REPORTED THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH FOR AN UNSPECIFIED REASON. THE CAUSE OF DEATH WAS NOT REPORTED. 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
    449705 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death