BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3051404 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08986
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO PATIENT LEFT HER PD PATIENT LINE OPEN WHILE GETTING UP TO CLOSE THE DOOR. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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.

    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 CAUSE PERITONITIS. THREE MONTHS PRIOR TO THIS REPORT, THE PT BEGAN TREATMENT WITH DIANEAL, LOW CALCIUM (LOCAL) PD4 AMBUFLEX AND DIANEAL PD4 LOCAL ULTRABAG THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). APPROXIMATELY TWO AND A HALF MONTHS LATER, THE PATIENT PRESENTED TO THE CLINIC WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY FLUID. ON THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH PERITONITIS BASED ON THE PATIENT'S SYMPTOMS AND ELEVATED LEUCOCYTES (WHITE BLOOD CELLS). ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE PERITONITIS . ON AN UNREPORTED DATE, THE PT RECEIVED ANTIBIOTIC THERAPY WITH GENTAMICIN AND VANCOMYCIN, IP (DOSES, FREQUENCIES AND LOTS NOT REPORTED). CONCOMITANT THERAPY WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE. THE PT WAS BEGINNING TO CONNECT TO THE PD DISPOSABLES TO PERFORM PD THERAPY AND HER CAT OPENED THE DOOR. THE PT LEFT HER PATIENT LINE OPEN WHILE GETTING UP TO CLOSE THE DOOR. TEN DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE PT WAS DISCHARGED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. PD THERAPY WAS ONGOING DURING THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149830 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R DIANEAL 2.5%, PD4, LOW CALCIUM AMBUFLEX| DIANEAL PD4, LOW CALCIUM ULTRABAG| DIANEAL 1.5%, PD4, LOW CALCIUM, AMBUFLEX