BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3143388 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14137
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OCCURRENCE DATE WAS UNKNOWN, HOWEVER, IT WAS REPORTED THE EVENT OCCURRED IN (B)(6) 2013. 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

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR KIDNEY FAILURE. ON AN UNREPORTED DATE, DIANEAL 1.5% WAS WITHDRAWN. DIANEAL 2.5% AND EXTRANEAL THERAPIES WERE ONGOING. THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS STARTED TREATMENT WITH VANCOMYCIN (EVERY 5 DAYS, IP, AND DOSE NOT REPORTED) FOR PERITONITIS. TREATMENT WITH VANCOMYCIN WAS STOPPED. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245337 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL 1.5%, DIANEAL 2.5%, EXTRANEAL