BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3072251 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10051
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 30, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    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. 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

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE CAUSE OF PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE BY THE HP. THE HP WAS TREATED WITH VANCOMYACIN IP (DOES AND FREQUENCY NOT REPORTED), FORTAZ IP (DOES AND FREQUENCY NOT REPORTED). THE HP WAS RETRAINED AND WAS REPORTED TO BE RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174945 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DIANEAL 2.5, EXTRANEAL AND HOME CHOICE