BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3062326 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09404
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 HAD A BREAK IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS PATIENT MADE MISTAKE (DETAILS NOT PROVIDED), DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN (1GM LOADING DOSE), REFLIN (250MG), AMIKACIN (125MG) AND MEROPENEM (500MG, IV), (ROUTES, FREQUENCIES AND LOTS NOT REPORTED) FOR THE PERITONITIS. CONCOMITANT THERAPY WAS NOT REPORTED. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162403 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R DIANEAL PD2 2.5% AMBUFLEX