BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6198044 · Received December 22, 2016

    Report

    Report Number
    1416980-2016-18641
    Event Type
    Death
    Date Received
    December 22, 2016
    Report Date
    January 17, 2017
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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, SEPTIC SHOCK AND SUBSEQUENTLY PASSED AWAY DUE TO AN UNKNOWN CAUSE. THE PERITONITIS WAS FURTHER DESCRIBED AS ¿AN INFECTION IN THE PERITONEUM¿ (NO FURTHER DETAIL WAS PROVIDED). THE CAUSE OF OR THE TREATMENT FOR THE PERITONITIS AND SUBSEQUENT SEPTIC SHOCK WAS NOT REPORTED. NO FURTHER INFORMATION WAS PROVIDED REGARDING WHETHER THE PATIENT WAS HOSPITALIZED FOR THE EVENT OR IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF THE PATIENT RECOVERED FROM THE PERITONITIS AND SUBSEQUENT SEPTIC SHOCK PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848472 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death