BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4142156 · Received October 4, 2014

    Report

    Report Number
    1416980-2014-34526
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) WHICH CAUSED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH INJECTION TOBRAMYCIN (40MG ONCE DAILY, ROUTE AND DURATION NOT REPORTED), INJECTION VANCOMYCIN (1 GM TWICE DAILY, ROUTE AND DURATION NOT REPORTED), AND INJECTION HEPARIN (5000 INTERNATIONAL UNITS, 1 ML PER EXCHANGE, ROUTE AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERED OR WAS RECOVERING FROM THE PERITONITIS EVENT. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621377 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 2.5% DIANEAL PD2 ULTRABAG