BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 2

    MDR report key: 16485473 · Received March 6, 2023

    Report

    Report Number
    16485473
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    December 11, 2021
    Report Date
    February 15, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADMITTED (B)(6) 2021. ON (B)(6) 2021 PT DEVELOPED INCREASED LOH AND DARK URINE. (NORMAL LOH RANGE 400-600). AST, ALT AND BILI WITHIN NORMAL RANGES. PT NOT ON HEPARIN AND ASPIRIN. ON LOW DOSE COUMADIN PRIOR TO "12/05" DUE TO BLEEDING ISSUES. STARTED HEPARIN AND ASPIRIN AND CONTINUED COUMADIN. ON (B)(6) LOH 736. ON (B)(6) PTT 59.5 AND INR 1.8. ON (B)(6) URINE RETURNED TO YELLOW COLOR AND LOH DECREASING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549351 HEARTMATE 2 LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention