BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 15999820 · Received December 16, 2022

    Report

    Report Number
    1416980-2022-06927
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 25, 2022
    Report Date
    December 16, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE EVENT ONSET, THE PATIENT WAS HOSPITALIZED AND TREATED WITH VANCOMYCIN INJECTION (1GM, ONCE IN 4 DAYS, DISCONTINUED AFTER 15 DAYS) AND FORTUM INJECTION (1GM, ONCE DAILY, DISCONTINUED AFTER 15 DAYS) FOR PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 15 DAYS AFTER THE EVENT ONSET. AT THE TIME OF THIS REPORT, THE PATIENT HAS RECOVERED FROM THE EVENT. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747671 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention| H COVIDIEN CATHETER| DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| UNKNOWN BAXTER PD DISPOSABLE