BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1131243 · Received August 12, 2008

    Report

    Report Number
    1828100-2008-00378
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    June 15, 2008
    Report Date
    August 12, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE SURGEON WANTED TO HAVE THE PT'S LOWER BODY PERFUSED. THE MAIN PUMP WAS IN USE WITH THE AUXILLARY ARTERY, SO THE PERFUSIONIST USED THE CARDIOPLEGIA PUMP WHEN THE AORTA WAS CLAMPED. THE PERFUSIONIST FAILED TO KEEP THE ARTERIAL HEAD ROLLING FAST ENOUGH FOR THE OTHER PUMP TO WORK, WHICH CAUSED AIR TO BE DRAWN IN OVER THE OXYGEN FIBERS RESULTING IN AN AIR EMBOLISM. NO MALFUNCTION OF THE DEVICE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 16401 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention