BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 18400708 · Received December 27, 2023

    Report

    Report Number
    1416980-2023-06768
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    December 2, 2023
    Report Date
    December 27, 2023
    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 A SUSPECTED PERITONITIS MANIFESTED BY CLOUDY PD FLUID. THE CAUSE OF PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. TWO DAYS AFTER THE EVENT ONSET, THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (1GM, EVERY 3RD DAY, INTRAPERITONEAL, ONGOING) AND CEFTAZIDIME INJECTION (1GM, ONCE DAILY, INTRAPERITONEAL, FOR FIVE DAYS, ONGOING) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENTS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325604 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention DIANEAL 2.5% PD2| EXTRANEAL 7.5% PD2| UNKNOWN BAXTER PD DISPOSABLES| UNKNOWN PD CATHETER