BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 5064299 · Received September 9, 2015

    Report

    Report Number
    1416980-2015-35271
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    July 24, 2015
    Report Date
    September 9, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HEALTH CARE PROFESSIONAL REPORTER DECLINED TO PROVIDE ADDITIONAL INFORMATION. H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT 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 SEPSIS AND THEN SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN, FEVER, CHILLS, AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE CAUSE OF THE SEPSIS WAS DUE TO THE PERITONITIS. TREATMENT FOR THE PERITONITIS AND SEPSIS EVENTS WAS NOT REPORTED. THE CAUSE OF DEATH WAS SEPSIS DUE TO PERITONITIS. ONE DAY AFTER ONSET OF SYMPTOMS, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR THE PERITONITIS EVENT AND WAS HOSPITALIZED AT THE TIME OF DEATH. THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS EVENT AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597068 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H DIANEAL 2.5% LOW CALCIUM ULTRABAG