BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYSIS LINE

    MDR report key: 20257042 · Received September 18, 2024

    Report

    Report Number
    MW5159719
    Event Type
    Death
    Date Received
    September 18, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 29, 2024
    Manufacturer
    UNK
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HIS SITUATION WAS VERY COMPLICATED. HE DIED OF SEPSIS DUE TO 3 DIFFERENT BACTERIAL STRAINS GROWING FROM HIS BLOOD, BUT HAD DIC, ACUTE RENAL FAILURE, AND (CRS) CYTOKINE RELEASE SYNDROME / (ICANS) IMMUNE EFFECTOR CELL ASSOCIATED NEUROTOXICITY. HIS STORY WAS ODD IN THAT HE HAD ANURIC RENAL FAILURE DEVELOP WITH HIS CRS RELATIVELY EARLY REQUIRING DIALYSIS START THEN DEVELOPED ICANS AND WAS IMPROVING FROM A PERSISTENT DECREASED LEVEL OF CONSCIOUSNESS BUT THEN DEVELOPED SEPSIS. ON THE DAY OF HIS DEATH, DIC (DISSEMINATED INTRAVASCULAR COAGULATION) WAS NOTED AND HIS DIALYSIS LINE CLOTTED, WHICH LEAD TO SEVERAL HOURS WITHOUT CONTINUOUS DIALYSIS, HIS BP AND PH DROPPED, EVENTUALLY WAS ON 5 VASOPRESSORS BEFORE DYING. THIS WAS INDIRECTLY RELATED TO HIS CART-CELL TOXICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296331 DIALYSIS LINE CATHETER, HEMODIALYSIS, IMPLANTED MSD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death YESCARTA