BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2992742 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05490
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OF PERITONITIS OCCURED ON AN UNKNOWN DATE IN (B)(6) 2012. 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

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED PERITONITIS. INITIALLY, IT WAS REPORTED THAT THE PERITONITIS WAS CAUSED BY A COMBINATION OF TOUCH CONTAMINATION, EXIT SITE PROBLEMS, AND A DECREASED IMMUNE SYSTEM. FURTHER INFORMATION RECEIVED CLARIFIED THAT THE PATIENT HAD BEEN ON METHOTREXATE AND THE PATIENT'S IMMUNE SYSTEM WAS COMPROMISED. ADDITIONALLY, IT WAS REPORTED THAT DUE TO THE PATIENT'S PSORIASIS CONDITION AND FLAKING SKIN, THE PATIENT HAS HAD A HARD TIME KEEPING THE EXCHANGE AREA CLEAN AND THIS CONTRIBUTED TO THE PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND DISCHARGED TWO DAYS LATER. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RETRAINED IN PROPER ASEPTIC TECHNIQUE AND HAS RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96667 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD4 AMBUFLEX, METHOTREXATE