BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3

    MDR report key: 21018708 · Received December 26, 2024

    Report

    Report Number
    21018708
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    February 4, 2024
    Report Date
    February 13, 2024
    Manufacturer
    ABBOTT
    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 ON (B)(6) 2024 WITH LOW FLOW ALARMS AND MILD SHORTNESS OF BREATH. LOW FLOW ALARMS CEASED AND NOTED IMPROVEMENT IN SHORTNESS OF BREATH AFTER 500 ML OF INTRAVENOUS FLUIDS GIVEN. LOH ON ADMISSION 353. LOH RANGE 260-400. CAT SCAN PERFORMED 2/5 WITH NOTED LONG SEGMENT OBSTRUCTION OF OUTFLOW GRAFT TRACT WITH 70% NARROWING INVOLVING THE MAJORITY OF THE BEND RELIEF. PATIENT TAKEN TO SURGERY ON 2/7 WITH BEND RELIEF INCISED AND IMMEDIATE RETURN OF SIGNIFICANT NUMBER OF PROTEINACEOUS DEBRIS. IMMEDIATE IMPROVEMENT IN LVAO FLOWS NOTED. 2/10 LOH 247.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732802 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE BEND DSQ ABBOTT 696028

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Life Threatening| R