BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3061546 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09406
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 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 THREE YEARS AGO, THE PT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PD AND ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED), IP, FOR PD. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED FURTHER DESCRIBED AS THE PT MADE A MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED), THE PT DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD AND PT DOES NOT CONSISTENTLY WEAR A MASK WHILE PERFORMING PD THERAPY. THE CAUSE OF THE PERITONITIS WAS ATTRIBUTED TO THE BREAK IN ASEPTIC TECHNIQUE. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT RECEIVED TREATMENT FOR THE PERITONITIS WITH FORTAZ, IP, (DOSE, FREQUENCY, AND LOT UNKNOWN). CONCOMITANT THERAPY WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PT WAS RECOVERED FROM THE PERITONITIS EVENT. ON AN UNREPORTED DATE IN THE MONTH FOLLOWING OCCURRENCE, THE PT RECEIVED RE-TRAINING IN ASEPTIC PROCEDURES FOR PD THERAPY. AT THE TIME OF THIS REPORT, DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163730 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention EXTRANEAL VIAFLEX| DIANEAL PD4 2/5%, LOW CALCIUM, AMBUFLEX