BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3243033 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19462
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 30, 2013
    Report Date
    June 30, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PT EXPERIENCED CONSTIPATION WHICH WAS REPORTED TO BE THE CAUSE OF THE PERITONITIS. ON THE SAME DAY AS THIS REPORT, THE PT WAS HOSPITALIZED FOR THE EVENT . THE PATIENT STARTED TREATMENT WITH INJECTION (INJ.) REFLIN (500 MG, FREQUENCY, AND ROUTE NOT REPORTED), INJ. FORTUM (500 MG, INTAPERITONEAL (IP), AND FREQUENCY NOT REPORTED), FLUCON (150 MG, ONCE DAILY, ROUTE NOT REPORTED), AND CIFRAN (250 MG, TWICE DAILY, ROUTE NOT REPORTED) FOR THE PERITONITIS. AT THE TIME OF THIS REPORT THE PERITONITIS WAS RESOLVED, THE PT WAS RECOVERED, AND DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343683 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R DIANEAL PD2 2.5% ULTRABAG