BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8623300 · Received May 20, 2019

    Report

    Report Number
    1416980-2019-02767
    Event Type
    Injury
    Date Received
    May 20, 2019
    Report Date
    May 20, 2019
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPERIENCED PERITONITIS ON AN UNREPORTED DATE REPORTED AS "RECENTLY". 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 PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH CALCITRIOL AND ANOTHER UNSPECIFIED DRUG (INTRAPERITONEAL, DOSES, DURATIONS AND FREQUENCIES NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT HAS RECOVERED FROM THE EVENT. PD THERAPY WAS ONGOING DURING TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE REPORTER DECLINED FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418906 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4 1.5%| DIANEAL PD4 2.5%