BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 17733292 · Received September 12, 2023

    Report

    Report Number
    1416980-2023-04617
    Event Type
    Death
    Date Received
    September 12, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 12, 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 PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED AND BEGAN TREATMENT WITH VANCOMYCIN INJECTION (1GM, EVERY 4TH DAY, INTRAPERITONEAL) AND CEFTAZIDIME INJECTION (1GM, ONCE DAILY, INTRAPERITONEAL) FOR PERITONITIS. FIVE DAYS AFTER BEING ADMITTED, THE PATIENT SUBSEQUENTLY PASSED AWAY IN THE HOSPITAL. THE CAUSE OF DEATH WAS REPORTED AS DUE TO PERITONITIS AND AN AUTOPSY WAS NOT PERFORMED. AT THE TIME OF DEATH, THE PATIENT WAS RECOVERING FROM PERITONITIS AND PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826774 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention| H| D DIANEAL 2.5% PD2| EXTRANEAL 7.5% PD2| UNKNOWN BAXTER PD DISPOSABLES| UNKNOWN PD CATHETER