BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3030252 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08065
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR (EXCHANGE DONE IN HOSPITAL WARD). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS IS UNKNOWN. THE PATIENT HAS RECOVERED FROM THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXCHANGE WAS DONE IN THE HOSPITAL WARD AND THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS TREATED WITH INJECTION REFLIN 1G ONCE DAILY (OD) IP AND INJECTION FORTUM 1G OD IP FOR PERITONITIS. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134986 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention