BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3170969 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15434
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF OCCURRENCE IS UNKNOWN. THE CAUSE OF THIS PERITONITIS WAS USE ERROR. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH CAUSED PERITONITIS. TREATMENT WAS REPORTED AS VANCOMYCIN 1 GRAM INTRAPERITONEALLY (IP) (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED). PER THE RN, THE CAUSE OF PERITONITIS WAS RELATED TO THE NURSING STAFF NOT USING PROPER ASEPTIC TECHNIQUE WHILE PERFORMING THE PATIENT'S PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND DISCHARGED FROM THE HOSPITAL. THE HOME PATIENT WAS READMITTED TO THE HOSPITAL A MONTH LATER WITH RECURRENT PERITONITIS. TREATMENT WAS FORTAZ 1 GRAM IP AND GENTAMICIN 80 MG IP DAILY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING. PERITONEAL DIALYSIS WAS ONGOING. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271149 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL