BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3

    MDR report key: 16240754 · Received January 24, 2023

    Report

    Report Number
    16240754
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    December 3, 2021
    Report Date
    December 10, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT ADMITTED (B)(6) 2021 WITH LOW FLOW ALARMS, FATIGUE, AND WEAKNESS. LVAD FLOW 2.6, PI 7.3 AND POWER 3.9. TAKING WARFARIN AS PRESCRIBED. INR RANGE 1.5-2.5 WITH SEVERAL LOW INRS THAT COINCIDE WITH HOSPITALIZATIONS. ON (B)(6) 2021 AST 126, ALT 85, T-BILI 1.4 AND LOH 277. CT SCAN ON (B)(6) 2021 WITH NOTED NON-OCCLUSIVE THROMBUS AND STENOSIS WITH KINKS TO OUTFLOW GRAFT. ON (B)(6) 2021 ECHO WITH SMALL LEFT VENTRICLE AND CANNULA ABUTTING SEPTUM. HEPARIN STARTED. CONTROLLER CHANGED WITH AN UPDATED PROGRAMMED CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202991 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE CONTR DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Unknown Required Intervention