BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 13666198 · Received March 4, 2022

    Report

    Report Number
    1416980-2022-00892
    Event Type
    Death
    Date Received
    March 4, 2022
    Date of Event
    February 5, 2022
    Report Date
    March 4, 2022
    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 MANIFESTED BY CLOUDY FLUID, VOMITING AND FATIGUE. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH INJECTION OF AMIKACIN (1GM DAILY, ONGOING), INJECTION OF CEFTAZIDIME, (1 GM DAILY, ONGOING), AND AN INJECTION OF HEPARIN (1CC DAILY, ONGOING). THE SAME DAY AS EVENT ONSET, THE PATIENT EXPERIENCED CARDIAC ARREST AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC ARREST. PD THERAPY WAS ONGOING PRIOR TO DEATH AND AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568597 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death| R DIANEAL 2.5% PD2| UNKNOWN BAXTER PD DISPOSABLES