BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 5073881 · Received September 14, 2015

    Report

    Report Number
    1416980-2015-35736
    Event Type
    Death
    Date Received
    September 14, 2015
    Date of Event
    July 6, 2015
    Report Date
    September 14, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF DEATH WAS REPORTED AS AN UNKNOWN DATE IN (B)(6) 2015 (ALSO REPORTED AS ¿BEFORE 10 DAYS¿). 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. 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 COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY, AND THE PATIENT SUBSEQUENTLY DIED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE DAY AFTER THE EVENT ONSET, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN (1G, ONCE DAILY, ROUTE AND DURATION NOT REPORTED) AND FORTUM (1G, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. ON AN UNKNOWN DATE (REPORTED AS BEFORE ONE MONTH, THE PD CATHETER WAS REMOVED DUE TO PERITONITIS AND PD THERAPY WAS DISCONTINUED (MODE OF DIALYSIS THERAPY HENCEFORTH WAS NOT REPORTED). DURING THIS TIME, THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS EVENT. ON AN UNKNOWN DATE THE FOLLOWING MONTH, THE PATIENT DIED. THE REPORTED CAUSE OF DEATH WAS REPORTED TO BE UNRELATED MEDICAL CONDITIONS; HOWEVER, 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
    604848 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death| H| R DIANEAL 1.5% ULTRABAG, DIANEAL 2.5% ULTRABAG