BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 9688336 · Received February 10, 2020

    Report

    Report Number
    1416980-2020-00532
    Event Type
    Death
    Date Received
    February 10, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 10, 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. IT WAS NOT REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. THE PATIENT WAS TREATED WITH INJECTION OF VANCOMYCIN (1GM. STAT DOSE, ONGOING, ROUTE NOT REPORTED) AND INJECTION OF CEFEPIME (1GM. DAILY, ONGOING, ROUTE NOT REPORTED) FOR THE PERITONITIS. THREE DAYS AFTER THE PERITONITIS ONSET, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS DUE TO CARDIAC ARREST. IT WAS REPORTED AN AUTOPSY WAS NOT PERFORMED. IT WAS REPORTED THE PATIENT WAS NOT RECOVERING FROM THE PERITONITIS EVENT PRIOR TO DEATH. IT WAS REPORTED PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151666 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R DIANEAL 1.5% PD2| DIANEAL 2.5% PD2