BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3830586 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16830
    Event Type
    Death
    Date Received
    May 23, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT HAD FATAL SEPSIS AND FATAL SMALL INTESTINAL NECROSIS WHICH IS ¿MORE LIKELY RELATED TO THE FATAL SEPSIS¿. THE SOURCE OF THE SMALL INTESTINAL NECROSIS OR SEPSIS WAS NOT REPORTED AND THEREFORE PERITONITIS AS THE SOURCE COULD NOT BE RULED OUT AS THE SOURCE OF THE INTESTINAL NECROSIS AND SEPSIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO PASSED AWAY COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308666 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL UNKNOWN