BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2964020 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03957
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS. THE COMPLAINT IS CONFIRMED BECAUSE IT WAS REPORTED THAT CUSTOMER EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE AND ACQUIRED PERITONITIS. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE IN (B)(6) THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED PERITONITIS. APPROXIMATELY ONE YEAR AGO, THE PATIENT BEGAN TREATMENT WITH PHYSIONEAL AND EXTRANEAL THERAPIES, INTRAPERITONEALLY (IP), FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS "MASK USE" (DETAILS NOT PROVIDED). A FEW DAYS PRIOR TO THIS REPORT, THE PATIENT WENT TO THE HOSPITAL FOR PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. ON THE SAME DATE, TREATMENT WITH CEFAZOLIN 1.5 G/DAY, IP, AND CEFTAZIDIME 1G/DAY, IP, WAS INITIATED. AFTER 3 DAYS, TREATMENT WITH CEFTAZIDIME ENDED AND THE PATIENT RECEIVED RE-TRAINING IN PROPER ASEPTIC PROCEDURE FOR PERFORMING PD THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS EVENT AND PHYSIONEAL AND EXTRANEAL THERAPIES WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69163 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R EXTRANEAL| PHYSIONEAL 40 1.36%