BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3914146 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21544
    Event Type
    Death
    Date Received
    July 3, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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). THE PATIENT WAS NOT HOSPITALIZED PRIOR TO DEATH. THE CAUSE OF DEATH WAS REPORTED AS ¿UNKNOWN, CARDIOVASCULAR¿. IT WAS REPORTED PD THERAPY WAS ONGOING AT THE TIME OF DEATH; HOWEVER, IT WAS NOT REPORTED IF THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF DEATH. 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
    391506 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death DIANEAL AND EXTRANEAL SOLUTIONS