BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3180627 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16023
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE AREA WAS NOT CLEANED BEFORE STARTING PERITONEAL DIALYSIS (PD) THERAPY AND THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS TREATED WITH INJECTION FORTUM 1GM CONTINUOUSLY INTRAPERITONEALLY (IP) AND INJECTION REFLIN 1GM INTRAPERITONEALLY (IP) (FREQUENCY NOT REPORTED) FOR PERITONITIS. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281581 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention DIANEAL PD2 2.5%