BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 9621685 · Received January 23, 2020

    Report

    Report Number
    9621685
    Event Type
    Death
    Date Received
    January 23, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 7, 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

    THE HEARTMATE II LVAD PT PRESENTED TO THE ED (B)(6) 2020 WITH COMPLAINTS OF FEELING WEAK AND DIZZY OVER THE LAST SEVERAL DAYS. PT HAS BEEN HAVING A HEADACHE AND HAD A NOSE BLEED THE MORNING OF (B)(6) 2020. THE PATIENT WAS SEEN BY ENT 3 WEEKS AGO DUE TO RECURRENT NOSEBLEEDS AND ELIQUIS DISCONTINUED PER ENT. THE LVAD TEAM WAS MADE AWARE. CT SCAN ORDERED AND SHOWED RIGHT OCCIPITAL INFARCT WITH EDEMA. NEUROLOGY CONSULTED AND PATIENT ADMITTED TO CVICU. PATIENT WAS DROWSY BUT AWAKE AND SPEAKING. AROUND 16:30, THE NURSE PRACTITIONER ON CALL WAS NOTIFIED BY BEDSIDE RN THAT MAP WAS CONSISTENTLY 60. AT THIS TIME, LEVOPHED WAS INITIATED TO MAINTAIN MAP >65. ARTERIAL LINE AND CENTRAL LINE WERE PLACED AT THE BEDSIDE. THE PATIENT BECAME MORE UNRESPONSIVE WITH INCREASING PRESSER REQUIREMENT. ABG WAS DONE AND RELATIVELY UNREMARKABLE OTHER THAN ELEVATED LACTATE. FAMILY WAS REACHED AND DECIDED TO KEEP THE PATIENT A FULL CODE. PATIENT WAS INTUBATED AND FOUND TO HAVE PROFOUND ACIDEMIA WITH INABILITY TO OBTAIN BP ON 100MCG OF LEVOPHED AND 0.1 UNITS OF VASOPRESSIN. THE LVAD CONSISTENTLY HAD A FLOW OF 0. THE FAMILY WAS UPDATED AND THE DECISION WAS MADE TO TURN OFF LIFE SUPPORT. TIME OF DEATH 0200 ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88037 ABBOTT HEARTMATE II LVAS DSQ ABBOTT 105306

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| L| O