BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3

    MDR report key: 15232246 · Received August 16, 2022

    Report

    Report Number
    15232246
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    August 7, 2022
    Report Date
    August 11, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD A VAD AND ON ANTICOAGULATION. SHE WAS FOUND BY FAMILY ALTERED IN BED. THE PATIENT WAS TAKEN TO AN OUTSIDE HOSPITAL (OSH) BY AMBULANCE. A HEAD CT AT OSH SHOWED LARGE ICH AND HYDROCEPHALUS. LABS NOTABLE FOR INR 3. THE PATIENT'S ANTICOAGULATION WAS REVERSED, AND THE PATIENT WAS TRANSPORTED BY BWH BY MED FLIGHT. THE PATIENT'S GOAL ANTICOAGULATION INR RANGE WAS 2-2.5. THE PATIENT WAS SUPRATHERAPEUTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915696 HEARTMATE 3 VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US HSC-090897

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA Female Life Threatening| R| H