BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3030343 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08068
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION (INJ). REFLIN (1GM, PER DAY, AND ROUTE NOT REPORTED) AND INJ. TOBRAMYCIN (40MG, PER 5TH DAY, AND ROUTE NOT REPORTED) FOR PERITONITIS. THE OUTCOME OF THIS PERITONITIS EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133765 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention DIANEAL ULTRABAG 1.5%| DIANEAL ULTRABAG 2.5%