BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3012738 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06677
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    October 28, 2012
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD), WHICH CAUSED PERITONITIS. THE PATIENT HAD A BREACH IN ASEPTIC, DESCRIBED AS TOUCH CONTAMINATION. LATER, THE PATIENT WAS DIAGNOSED WITH AND WAS HOSPITALIZED FOR BACTERIAL PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT RECEIVED PIPERACILLIN, 2.25GM, INTRAVENOUS (IV) FOR A ONE TIME DOSE, VANCOMYCIN, 1GM, INTRAPERITONEALLY (IP) EVERY 3RD DAY FOR AN UNKNOWN NUMBER OF DAYS, FORTAZ, 2GM, IP DAILY FOR AN UNKNOWN NUMBER OF DAYS, AND CIPRO, 500MG, BY MOUTH TWICE DAILY FOR AN UNKNOWN NUMBER OF DAYS. THE PATIENT WAS DISCHARGED BUT A LATER CULTURE OF THE PATIENT'S PD EFFLUENT REVEALED A FUNGAL PERITONITIS AND THE PATIENT WAS STARTED ON FLUCONAZOLE, 200MG, BY MOUTH DAILY FOR AN UNKNOWN NUMBER OF DAYS. THE PATIENT'S PERITONEAL DIALYSIS CATHETER WAS REMOVED AND THE PATIENT WAS STARTED ON HEMODIALYSIS. THE PATIENT RECOVERED FROM THE PERITONITIS EVENTS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116378 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R EXTRANEAL| DIANEAL LOW CAL 2.5% AMBUFLEX