BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3821867 · Received May 20, 2014

    Report

    Report Number
    1416980-2014-16285
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH INJECTION CILANEM 250 MG IP TWICE DAILY (DOSES NOT REPORTED) AND INJECTION MIPENEM 250 MG IP TWICE DAILY (DOSES NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERED FROM THE PERITONITIS EVENT AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300312 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 Hospitalization| R DIANEAL PD2 1.5% AND 2.5% ULTRABAG