BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3871152 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18839
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH 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 THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT (PT) EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH RESULTED IN PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE ATTENDANT PERFORMED CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS) WITHOUT PROPER CARE AND TRAINING FROM THE CLINICAL COORDINATOR. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH INJECTION VANCOGEN (1 GRAM IP; FREQUENCY NOT REPORTED) AND PEPRACIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. ON AN UNREPORTED DATE, THE PT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PT'S PD FLUID WAS FOUND TO BE CLEAR AND THE PT RECOVERED FROM THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351032 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL 2.5% ULTRABAG