BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2120901 · Received June 12, 2011

    Report

    Report Number
    1423500-2011-07483
    Event Type
    Injury
    Date Received
    June 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF STERILE PERITONITIS IN A PATIENT (AGE NOT REPORTED) COINCIDENT WITH IMPORTED EXTRANEAL VIAFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX IMPORTED FROM TURKEY (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY CLOUDY PERITONEAL EFFLUENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE NOT REPORTED). IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED, OR IF LABORATORY DATA OR DIAGNOSTIC TESTING WERE PERFORMED. IT WAS NOT REPORTED IF EXTRANEAL VIAFLEX THERAPY WAS ONGOING OR IF THE EVENT OF STERILE PERITONITIS HAD RESOLVED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF STERILE PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL VIAFLEX