BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2963714 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03925
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS CAUSED BY A USE ERROR-BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING MANUAL 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 PERITONITIS CAUSED BY A TOUCH CONTAMINATION. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS UNKNOWN. RETRAINING ON ASEPTIC TECHNIQUE WAS PERFORMED. THE PATIENT'S PD CATHETER WAS REMOVED, DIANEAL THERAPY WAS DISCONTINUED, AND THE PATIENT BEGAN HEMODIALYSIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERED FROM THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67338 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization DIANEAL PD4 LOW CALCIUM