BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3023409 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07424
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 EVENT 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 REPORTED EVENT WAS USE ERROR. 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 (HP) WHO HAD A BREAK IN ASEPTIC TECHNIQUE, WHICH CAUSED PERITONITIS. THE HP HAD A BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS THE HP MADE A MISTAKE AND DID NOT CLEAN THE AREA PRIOR TO STARTING PERITONEAL DIALYSIS THERAPY. THE HP EXPERIENCED PERITONITIS AND WAS TREATED WITH INJECTION FORTUM (250G, INTRA-PERITONEALLY, IN EACH BAG FOR 14 DAYS) AND INJECTION VANCOMYCIN (2GM, 1ST AND 7TH DAYS, ROUTE NOT REPORTED). THE HP WAS NOT HOSPITALIZED FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE HP HAD RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126263 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DIANEAL 2.5% ULTRABAG