BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8784962 · Received July 12, 2019

    Report

    Report Number
    1416980-2019-03744
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 19, 2019
    Report Date
    July 12, 2019
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 AND TREATMENT FOR THE PERITONITIS WERE NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE REPORTER DECLINED FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579740 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other DIANEAL PD4 WITH 2.5%| EXTRANEAL 7.5%