BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3241057 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19308
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 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). 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ONE DAY AFTER BEGINNING PERITONEAL DIALYSIS (PD) THERAPY, A HOME PATIENT (HP) EXPERIENCED PERITONITIS. THE DAY BEFORE THE ONSET OF PERITONITIS, THE PATIENT WAS ALSO HOSPITALIZED FOR AN UNREPORTED INDICATION. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH INJECTION OF FORTUM IP (250MG, TWICE (BID)). AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL IN THE HOSPITAL. OUTCOME OF PERITONITIS WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340362 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention DIANEAL PD2 1.5% ULTRABAG