BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4182355 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36347
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN. THE SERVICE HISTORY REVIEW, DEVICE HISTORY REVIEW, EVENT HISTORY LOG REVIEW, AND SAMPLE ANALYSIS WERE NOT PERFORMED AS PART OF THE EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THIS PATIENT¿S DEATH IS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED PRIOR TO DEATH. DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH; HOWEVER, IT WAS NOT REPORTED IF THE PATIENT WAS ON THERAPY 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
    661743 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| O DIANEAL