BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3894690 · Received June 25, 2014

    Report

    Report Number
    1416980-2014-20271
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH AN INJECTION OF FORTUM 1GRAM, ONCE DAILY INTRAVENOUSLY. THE CAUSE OF THE PERITONITIS WAS A BREACH IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371137 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention DIANEAL PD-2 2.5% SOLUTION