BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 7263330 · Received February 12, 2018

    Report

    Report Number
    1416980-2018-00687
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    January 20, 2018
    Report Date
    February 12, 2018
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; 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

    A PERITONEAL DIALYSIS PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE SAME DAY AS EVENT ONSET, THE PATIENT WAS TREATED WITH INJECTION OF VANCOMYCIN (1 GM AFTER FIVE DAYS, ROUTE NOT REPORTED) AND INJECTION OF FORTUM (1 GM DAILY, ROUTE NOT REPORTED). DIANEAL THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT AND ANTIBIOTIC THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108433 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention DIANEAL 2.5% PD2