BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2931879 · Received January 28, 2013

    Report

    Report Number
    1416980-2013-02085
    Event Type
    Death
    Date Received
    January 28, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFORMATION WAS RECEIVED FROM A BAXTER EMPLOYED HEALTH PROFESSIONAL FROM (B)(6) AS FOLLOWS. THE CASE WAS MEDICALLY CONFIRMED. THE PATIENT DIED DUE TO SEPTICEMIA (ONSET DATE NOT REPORTED). THE CAUSE OF THE SEPTICEMIA WAS NOT REPORTED. TREATMENT WAS NOT REPORTED. THE PERITONITIS WAS STILL ONGOING AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, MANUFACTURER SITE IS UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT'S TREATMENT STARTED WITH INJECTION (INJ) REFLIN 1GM/DAY AND INJ TOBRAMYCIN 40MG/DAY (ROUTES NOT REPORTED) FOR THE PERITONITIS. THE OUTCOME OF THIS PERITONITIS EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37818 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death| R DIANEAL PD2 1.5% ULTRABAG