BEUDAMED
    FDA Adverse Event Summary report: N

    SARNS

    MDR report key: 1070207 · Received June 27, 2008

    Report

    Report Number
    1070207
    Date Received
    June 27, 2008
    Date of Event
    June 15, 2008
    Report Date
    June 23, 2008
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTQ
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WITH A DISSECTING AORTA WAS TAKEN EMERGENTLY TO THE OR FOR REPAIR, AND WAS PLACED ON THE HEART-LUNG MACHINE WITH A 5-PUMP BASE, AS THE SURGEON WANTED TO HAVE THE LOWER BODY PERFUSED. THE MAIN PUMP WAS IN USE WITH THE AXILLARY ARTERY, SO THE PERFUSIONIST USED THE CARDIOPLEGIA PUMP WHEN THE AORTA WAS CLAMPED. SHE 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. AN AIR EMBOLISM WAS INTRODUCED INTO THE PATIENT'S CIRCULATORY SYSTEM. HE WAS TAKEN TO THE ICU AND PUT INTO A BARBITURATE COMA FOR A FEW DAYS. HE HAS SINCE BEEN TAKEN OFF, HAS BEEN FOLLOWING COMMANDS, AND SEEMS TO HAVE NO FOCAL DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS HEART LUNG MACHINE DTQ TERUMO MEDICAL CORPORATION 8000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR