BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1298803 · Received January 27, 2009

    Report

    Report Number
    1298803
    Event Type
    Injury
    Date Received
    January 27, 2009
    Date of Event
    December 12, 2008
    Report Date
    January 18, 2009
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    MNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING OPEN HEART SURGERY, AIR ENTERED THE PATIENT'S AORTA, REQUIRING IMMEDIATE CLAMPING OF THE AORTA AND STEEP TRENDELENBURG (HEAD DOWN) POSITIONING OF THE PATIENT TO PREVENT AIR EMBOLISM TO THE PATIENT'S HEAD. SURGEON SUSPECTED THAT THE TERUMO OVER PRESSURE SAFETY VALVE FAILED, ALLOWING AIR INTO THE AORTA THROUGH THE AORTIC ROOT CANNULA AND CARDIOPLEGIA CANNULA SYSTEM. THE PATIENT EXHIBITED SYMPTOMS OF RIGHT CEREBROVASCULAR ACCIDENT (STROKE) POSTOPERATIVELY WITH LEFT SIDED WEAKNESS, WHICH RESOLVED WITHIN 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * OVERPRESSURE SAFETY VALVE MNJ TERUMO CARDIOVASCULAR SYSTEMS CORP. LH130 KF05

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Hospitalization