BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3932993 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22578
    Event Type
    Death
    Date Received
    July 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    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 TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION AND THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN. AS A RESULT, A SERVICE HISTORY REVIEW AND/OR DEVICE HISTORY REVIEW WERE NOT PERFORMED AS PART OF THE INVESTIGATION. BASED ON INSUFFICIENT REPORTED INFORMATION AND LACK OF A DEVICE EVALUATION, IT IS NOT POSSIBLE TO DETERMINE DEVICE CAUSALITY FOR THE REPORTED EVENT. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH IS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED AT THE TIME OF DEATH. IT WAS UNKNOWN IF THERAPY WAS ONGOING AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411335 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death