BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 9902580 · Received March 19, 2020

    Report

    Report Number
    9902580
    Event Type
    Death
    Date Received
    March 19, 2020
    Date of Event
    March 16, 2020
    Report Date
    March 17, 2020
    Manufacturer
    ABBOTT
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IS A HEARTMATE II LVAD PT (DOI: (B)(6) 2013) THAT PRESENTED ON (B)(6) 2020 WITH SEPSIS 2/2 CHRONIC PSEUDOMONAL DRIVELINE INFECTION. PT DEVELOPED ACUTE KIDNEY FAILURE WITH SIGNIFICANT VOLUME OVERLOAD AND PULMONARY EDEMA REQUIRING DIALYSIS (INITIATED (B)(6) 2020) 2/2 PRESUMPTIVE TOBRAMYCIN TREATMENT FOR HIS INFECTION. SUBSEQUENTLY, PATIENT HAD AN ACUTE CHANGE IN MENTATION PROMPTING A BRAIN ATTACK, ALSO ON (B)(6) 2020, WITH HEAD CT SIGNIFICANT FOR BILATERAL SUBARACHNOID HEMORRHAGES. PATIENT WAS INTUBATED ON (B)(6) 2020 FOR ACUTE RESPIRATORY FAILURE AND INABILITY TO CLEAR SECRETIONS. PATIENT THEN BECAME HYPOTENSIVE REQUIRING LARGE AMOUNTS OF VASOACTIVE MEDICATIONS. THE PATIENT WAS CHANGED TO A DNR CODE STATUS 4 ON (B)(6) 2020. GIVEN THE ACUTE PROGRESSIVE DECLINE OF THE PATIENT'S CONDITION AND POOR PROGNOSIS, A FAMILY MEETING WAS REQUESTED. ON (B)(6) 2020, THE PATIENT'S WIFE REQUESTED THAT THE PATIENT BE MADE COMFORTABLE AND ALL AGGRESSIVE MEASURES BE STOPPED, INCLUDING CRRT, THE LVAD AND THE VENTILATOR. PATIENT PASSED AWAY ON (B)(6) 2020. CAUSE OF DEATH: CHF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321743 ABBOTT HEARTMATE II LVAS DSQ ABBOTT 125677

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H| L