BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3031387 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08133
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 14, 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). A SAMPLE WAS NOT REQUESTED AS THIS EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS REPORT OF PERITONITIS CAUSED BY USE ERROR-BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED. THE ROOT CAUSE OF THE USE ERROR WAS UNDETERMINED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A 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, A BREAK IN ASEPTIC TECHNIQUE HAD OCCURRED, FURTHER DESCRIBED AS PATIENT MADE MISTAKE AND ATTENDANT DOING DIALYSIS WITHOUT PROPER TRAINING FROM BAXTER CLINICAL COORDINATOR. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS DUE TO A BREAK IN ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION VENCOGEN (1GM IP, 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
    134180 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R DIANEAL PD2 2.5% ULTRABAG