BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4222819 · Received November 4, 2014

    Report

    Report Number
    1416980-2014-38644
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT 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 A LEAK THAT RESULTED IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS EVENT WAS REPORTED TO BE A LEAKAGE OF THE TRANSFER SET. THE PATIENT WAS HOSPITALIZED FOR AN UNREPORTED INDICATION PRIOR TO BEING DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN (2 GRAM, ONCE DAILY FOR 5 DAYS, INTRAPERITONEALLY), INJECTION FORTUM (1 GRAM, ONCE DAILY FOR 14 DAYS, ROUTE NOT REPORTED) AND FORCAN (ORALLY, 100 MILLIGRAM, ONCE DAILY AT BEDTIME) FOR THE EVENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS REPORTED TO HAVE RECOVERED FROM THE EVENT. ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707515 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention DIANEAL 2.5% ULTRABAG, EXTRANEAL