BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3930003 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22375
    Event Type
    Death
    Date Received
    July 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT AGE: THE PATIENT WAS BORN ON AN UNSPECIFIED DATE IN 1960. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER IS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CAUSE OF THE REPORTED DEATH COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF PERITONEAL DIALYSIS THERAPY WAS ONGOING UNTIL 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
    407178 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXTRANEAL, PHYSIONEAL 40 1.36% AND 2.27%