BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3243802 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19533
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    May 12, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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, WHERE THE HOME PATIENT (HP) DID NOT WASH HANDS BEFORE DOING AN EXCHANGE, DURING PERITONEAL DIALYSIS (PD) THERAPY WHILE USING UNKNOWN BAXTER PD DISPOSABLES, WHICH CAUSED PERITONITIS. ON THE DAY OF THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS DETERMINED TO BE TOUCH CONTAMINATION WHERE THE HP MADE A MISTAKE. TREATMENT WAS NOT REPORTED. ALMOST SIX WEEKS AFTER BEING HOSPITALIZED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERED FROM PERITONITIS AND PD THERAPY WAS ONGOING. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343819 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization DIANEAL PD4 1.5% AND 2.5% ULTRABAGS