BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4182162 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36329
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE PATIENT PASSED AWAY. THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR EVALUATION. THE EVENT HISTORY LOG REVIEW REVEALED NO ALARM OR IIPV EVENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE SAMPLE ANALYSIS REVEALED NO NON-CONFORMING PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. VISUAL INSPECTION AND FUNCTION TESTING WERE PERFORMED WITHOUT ANY ISSUES FOUND. THE POWER ON SELF-TEST WAS SUCCESSFULLY PERFORMED. AS A RESULT, THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. THE SERVICE HISTORY REVIEW WAS NOT PERFORMED BECAUSE THERE WERE NO PREVIOUS SERVICE EVENTS IN THE PAST YEAR. THE DEVICE HISTORY REVIEW WAS NOT PERFORMED BECAUSE THERE WERE PREVIOUS SERVICE EVENTS SINCE THE MANUFACTURE OF THE DEVICE. 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

    IT WAS REPORTED THAT A PATIENT DIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661481 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death