BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3024087 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07503
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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 USE ERROR-BREACH IN ASEPTIC TECHNIQUE, WHICH CAUSED PERITONITIS 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. 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 PERITONITIS CAUSED BY A BREAK IN ASEPTIC TECHNIQUE/TOUCH CONTAMINATION. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND DIARRHEA AND WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS. ON THAT SAME DAY, THE PATIENT BEGAN TREATMENT WITH CEFEPIME, 1 GRAM, IP, DAILY FOR 14 DAYS. TWO DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. PERITONEAL DIALYSIS THERAPY WAS ONGOING. THE PATIENT RECOVERED FROM THE ABDOMINAL PAIN AND DIARRHEA ON AN UNKNOWN DATE AND WAS RECOVERING FROM THE EVENT OF PERITONITIS. ALL AVAILABLE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125625 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R HOMECHOICE| DIANEAL LOW CALCIUM AMBULEX