BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3073102 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10088
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. ON AND UNREPORTED DATE, THE PT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX THERAPIES (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, THE PT EXPERIENCED SOME TYPE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED). THE PT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THE NEXT DAY. TREATMENT WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. FOUR DAYS LATER, THE PT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT THE PT WAS RECOVERING FROM THE PERITONITIS AND DIANEAL THERAPIES WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173392 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization DIANEAL PD2 1.5%| DIANEAL PD2 2.5%