BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3202921 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17059
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 HOME PATIENT WAS GIVEN A NEW CAREGIVER AND BELIEVES THE CHANGE IN CAREGIVERS LED TO PERITONITIS (NO ADDITIONAL SPECIFIC DETAILS OBTAINED. THE HOME PATIENT WAS HOSPITALIZED FOR THE EVENT, THE PATIENT WAS TREATED WITH INJECTION (INJ) REFLIN AND INJ. FORTUM (500 MG, INTRAPERITONEALLY (IP) AND FREQUENCIES 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
    300834 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL