BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3083479 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10728
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 6, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ANY FURTHER RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING THE PERITONEAL DIALYSIS PROCEDURE. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY PERITONEAL CLOUDY EFFLUENT. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED MEDICATION. THE NURSE STATED THAT PERITONITIS WAS LIKELY DUE TO BREAK IN ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184523 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL