BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3092889 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11316
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXACT DATE IS UNKNOWN; REPORTED AS (B)(6) 2013. 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. 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 CAUSED PERITONITIS. ON AN UNREPORTED DATE APPROXIMATELY 3 YEARS PRIOR TO THIS REPORT, THE PT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN THE MONTH PRIOR TO THIS REPORT, THE PT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS THE PATIENT MADE A MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED). THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. TREATMENT WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. ON AN UNSPECIFIED DATE, THE PT RECOVERED FROM THE PERITONITIS. ON AN UNREPORTED DATE, THE PT WAS RE-TRAINED ON PROPER ASEPTIC TECHNIQUE FOR PERFORMING PD THERAPY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195313 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXTRANEAL| DIANEAL PD4 2.5%, LOW CALCIUM, AMBUFLEX