BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3010442 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06552
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT REQUESTED AS THIS EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS REPORT OF PERITONITIS CAUSED BY USE ERROR-BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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. THE ROOT CAUSE OF THE USE ERROR WAS UNDETERMINED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT THAT EXPERIENCED PERITONITIS RELATED TO A BREACH IN ASEPTIC TECHNIQUE. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. PRIOR TO OBTAINING AN EFFLUENT CULTURE, THE PATIENT WAS TREATED IN THE EMERGENCY DEPARTMENT WITH 750 MG (INTRAVENOUS) IV VANCOMYCIN, ONE DOSE (FREQUENCY NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS NOT YET RETRAINED DUE TO ONGOING HOSPITALIZATION. THE PATIENT WAS STILL HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113070 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R DIANEAL