BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2962190 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03808
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS. THE COMPLAINT IS CONFIRMED BECAUSE THE NURSE REPORTED A BREAK IN ASEPTIC TECHNIQUE BY PATIENT DESCRIBED AS A TOUCH CONTAMINATION. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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. 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 HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THAT FIVE DAYS PRIOR, THE HOME PATIENT (HP) HAD EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. ON AN UNSPECIFIED DATE, THE HP WAS STARTED ON VANCOMYCIN FOR TREATMENT OF THE PERITONITIS (DOSE, FREQUENCY, LOT NUMBER NOT REPORTED). AT THE TIME OF THE REPORT THE PATIENT WAS STILL HOSPITALIZED AND TREATMENT FOR THE PERITONITIS WAS ONGOING. THE CONSUMER REPORTED THE CAUSE OF THE PERITONITIS WAS UNKNOWN. AT THE TIME OF THE INITIAL REPORT, INTRA-PERITONEAL (IP) DIANEAL THERAPY FOR AUTOMATED PERITONEAL DIALYSIS (APD) WAS ONGOING. DURING FOLLOW UP WITH A PD NURSE (PDN), ADDITIONAL INFORMATION WAS RECEIVED. THE PDN CONFIRMED THE PATIENT'S CASE OF PERITONITIS. THE PDN REPORTED THE CAUSE OF THE PERITONITIS WAS A TOUCH CONTAMINATION BY THE PATIENT (DETAILS NOT PROVIDED). THE PDN STATED, THE CULTURE RESULT IS UNKNOWN DUE TO BEING DONE IN THE HOSPITAL. AT THE TIME OF THE FOLLOW UP, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT'S PD CATHETER WAS REMOVED. ON AN UNREPORTED DATE THE PATIENT WAS STARTED ON HEMODIALYSIS, WHICH IS ONGOING AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65698 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R DIANEAL PD4 AMBUFLEX