BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3232792 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18809
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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 THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH CAUSED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT STARTED TREATMENT WITH FORTAZ INTRAPERITONEALLY (IP) (DOSE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334130 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX