BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3243976 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19544
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS TOUCH CONTAMINATION DURING PERITONEAL DIALYSIS (PD) THERAPY WHILE USING UNKNOWN BAXTER PD DISPOSABLES, WHICH CAUSED PERITONITIS. THE HOME PATIENT (HP) WAS HOSPITALIZED FOR FOUR DAYS FOR THE EVENT. THE HP WAS TREATED WITH UNKNOWN ANTIBIOTICS. THE PATIENT WAS RECOVERED FROM PERITONITIS. THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUES. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343080 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R DIANEAL 4D 1.5% AND 2.5% SINGLEBAGS