BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3981106 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25357
    Event Type
    Death
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    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 UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE HC DEVICE AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457450 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death DIANEAL PD4 1.5% AND 2.5%