BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3895186 · Received June 25, 2014

    Report

    Report Number
    1416980-2014-20305
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 31, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION 1GM STAT (ROUTE, DURATION, AND FREQUENCY NOT REPORTED) AND FORTUM INJECTION 1GM (ROUTE, DURATION, AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE IT WAS REPORTED THAT THE PATIENT¿S EFFLUENT FLUID WAS CLEAR. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371071 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL 1.5% PD2 ULTRABAG