BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3

    MDR report key: 18972530 · Received March 25, 2024

    Report

    Report Number
    18972530
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    December 27, 2022
    Report Date
    January 6, 2023
    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

    'PATIENT WITH VAD ALARMS ON (B)(6) 2022 NOTIFIED VAD OFFICE AND WAS TOLD TO HYDRATE. PT THEN BEGAN HAVING SHORTNESS OF BREATH, NAUSEA AND VOMITING. ADMITTED (B)(6) IN CARIOGENIC SHOCK. LACTATE ON ADMISSION 5.9 WITH T­ BILI 3.6 AND LOH 305 (NORMAL RANGE 100-200 RANGE). VAD FLOWS DECREASED TO 2-3 RANGE (NORMAL FLOW RANGE IN 6'S). ECHO WITH RAMP STUDY WITH NO LV COMPRESSION. CT PERFORMED WITH NOTED DEBRIS IN RELIEF BEND COMPRESSING OUTFLOW GRAFT. UNDERWENT BEND RELIEF SURGERY ON "(B)(6)" WITH IMPROVEMENT IN FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408725 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention