BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1792023 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02356
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS. ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE "PATIENT MADE A MISTAKE AND AREA NOT CLEAN BEFORE STARTING PERITONEAL DIALYSIS." ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS ON THE SAME DAY. ON (B)(6) 2010, A PERITONEAL ANALYSIS WAS PERFORMED. THE ANALYSIS REVEALED 600 CELLS/MM 3 LEUCOCYTES WITH 28% NEUTROPHILS AND 72% LYMPHOCYTES. NO PERITONEAL EFFLUENT CULTURE WAS DONE. ON (B)(6) 2010 THE PATIENT BEGAN REMEDIAL THERAPY WITH INEM (500MG, DAILY, IV) AND VANCOMYCIN (1GM, LOADING DOSE, IV). THERAPY WAS ONGOING AS WELL AS REMEDIAL THERAPY WITH INEM. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE OR IF THE EVENT RESOLVED. IT WAS UNKNOWN IF THE PERITONITIS RESOLVED. A CAUSALITY STATEMENT WAS NOT REPORTED FOR THE BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R DIANEAL ULTRABAG