BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3232083 · Received July 17, 2013

    Report

    Report Number
    1416980-2013-18777
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH INJ. REFLIN (1GM PER DAY, ROUTE NOT REPORTED) AND INJ. TOBRAMYCIN (40MG PER DAY, ROUTE NOT REPORTED). IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331441 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention DIANEAL PD2 2.5% ULTRABAG