BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 10460737 · Received August 27, 2020

    Report

    Report Number
    1416980-2020-05245
    Event Type
    Death
    Date Received
    August 27, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 27, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    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 (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THREE DAYS AFTER EVENT ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTION OF VANCOMYCIN (1GM, ROUTE AND FREQUENCY NOT REPORTED) AND INJECTION OF CEFTAZIDIME (1GM, ROUTE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. FOUR DAYS AFTER EVENT ONSET, THE PATIENT EXPERIENCED CARDIAC ARREST. THE SAME DAY, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS DUE TO CARDIAC ARREST. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT AT THE TIME OF DEATH. ANTIBIOTIC AND PD THERAPY WERE ONGOING AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923118 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R DIANEAL PD2 2.5%