BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2103295 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06521
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYEE NURSE FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR E. COLI IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL PD2 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION INTRAVENOUSLY (IV) 500MG ONCE IN 96 HOURS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN WHETHER THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR E. COLI RESOLVED. IT WAS NOT REPORTED WHETHER DIANEAL PD2 ULTRABAG THERAPY WAS CONTINUED. THE REPORTER BELIEVED THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR E. COLI WAS UNRELATED TO DIANEAL PD2 ULTRABAG THERAPY. FOLLOW-UP INFORMATION ((B)(6) 2011): FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTING NURSE. THE PATIENT'S OUTCOME WAS REVISED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED WITH SEQUELAE. THE CATHETER WAS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R DIANEAL PD2 ULTRABAG