BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3191890 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16512
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED FURTHER DESCRIBED AS A PATIENT MADE A MISTAKE; SUBSEQUENTLY, THE PATIENT DEVELOPED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN INTRAPERITONEALLY (IP) (1.5GM LOADING DOSE, FREQUENCY NOT REPORTED), INJECTION FORTUM IP (1.5 GM LOADING DOSE AND 250 MG, FREQUENCY NOT REPORTED) AND INJECTION AZOPEN INTRAVENOUSLY (IV) TWICE A DAY FOR PERITONITIS. THE PATIENT WAS STILL HOSPITALIZED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291614 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R DIANEAL PD2 2.5% AMBUFLEX