BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 18668467 · Received February 8, 2024

    Report

    Report Number
    1416980-2024-00427
    Event Type
    Death
    Date Received
    February 8, 2024
    Report Date
    February 8, 2024
    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. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION (1GM, INTRAPERITONEAL, AFTER EVERY 3 DAYS, DISCONTINUED) AND MEROPENEM INJECTION (1GM, INTRAPERITONEAL, ONCE DAILY, FOR 5 DAYS, DISCONTINUED) FOR PERITONITIS. IT WAS REPORTED THE PATIENT PASSED AWAY (UNKNOWN DATE). THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. PRIOR TO DEATH, PD THERAPY WAS DISCONTINUED, AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS THERAPY. IT WAS FURTHER REPORTED THE PATIENT WAS NOT RECOVERED FROM PERITONITIS AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787840 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1