BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3935688 · Received July 15, 2014

    Report

    Report Number
    1416980-2014-22654
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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 EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH RESULTED IN PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. THE SAME DAY, THE PATIENT WAS HOSPITALIZED AND BEGAN TREATMENT WITH VANCOMYCIN IV AND IP (DOSE, FREQUENCY, AND ADMINISTRATION RATE WERE NOT REPORTED). SEVEN DAYS AFTER THE ONSET OF PERITONITIS, VANCOMYCIN THERAPY WAS DISCONTINUED, THE PATIENT WAS RECOVERED FROM THE EVENT AND DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412861 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R DIANEAL PD2 1.5%, 2.5% AND 4.25% AMBUFLEX