BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3945857 · Received July 21, 2014

    Report

    Report Number
    1416980-2014-23412
    Event Type
    Death
    Date Received
    July 21, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE YEAR OF THE PATIENT'S BIRTH WAS REPORTED AS (B)(6). 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND SEPTICEMIA COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE PERITONITIS AND SEPTICEMIA WERE MANIFESTED BY FEVER, ABDOMINAL PAIN, AND DEBILITATION. THE CAUSE OF THE PERITONITIS AND SEPTICEMIA WAS NOT REPORTED. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. TREATMENT WAS NOT REPORTED. THE NEXT DAY, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE PERITONITIS AND SEPTICEMIA. DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425366 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H DIANEAL PD4 1.5%, DIANEAL PD4 2.5%