BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3193500 · Received June 27, 2013

    Report

    Report Number
    1416980-2013-16524
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE
    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 DESCRIBED AS A BREAK IN ASEPTIC TECHNIQUE. 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 PERITONITIS CAUSED BY A BREAK IN ASEPTIC TECHNIQUE COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. PD THERAPY WAS ONGOING. THE PATIENT WAS TREATED WITH AMIKACIN (250MG, BD) AND REFLIN (500MG, PER DAY, OD). FOUR DAYS AFTER HOSPITAL ADMISSION THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT RECOVERED. THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294254 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R DIANEAL 2.5% ULTRABAG| DIANEAL 1.5% ULTRABAG