BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2434642 · Received January 27, 2012

    Report

    Report Number
    1828100-2012-00071
    Event Type
    Death
    Date Received
    January 27, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 17, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS CERTIFIED BY TERUMO FIELD SERVICE REP AS BEING FULLY FUNCTIONAL AND ALL PUMPS AND SAFETY SYSTEMS WORKED TO DESIGNED SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN (B)(6) FEMALE WAS SCHEDULED FOR AN AORTIC ARCH ANEURYSM REPAIR AND THE PROCEDURE, INCLUDING CARDIOPULMONARY BYPASS (CPB) LASTED MORE THAN TWELVE HOURS. THE CIRCUIT INCLUDED: TERUMO 8000 PERFUSION SYSTEM, GISH MPS CARDIOPLEGIA KIT AND SORIN OXYGENATOR AND PERFUSION CUSTOM PACK. THE OXYGENATOR RESERVOIR BECAME PRESSURIZED LATE IN CPB AND AIR WAS PUSHED UP THE VENOUS LINE INTO THE PT. THIS REQUIRED URGENT AIR REMOVAL OF THE HEART AND CIRCULATION, AS WELL AS CHANGE OUT OF THE OXYGENATOR AND RESERVOIR. THIS REQUIRED REMOVAL FROM CPB FOR A PERIOD OF TIME AND LACK OF CIRCULATION DURING THIS PERIOD. SHORTLY AFTER THE SURGICAL REPAIR, THE PT EXPIRED. THE HOSPITAL STAFF DID NOT BELIEVE THE TERUMO 8000 PERFUSION SYSTEM HAD ANY ROLE IN THE PT OUTCOME. NO PRODUCT ISSUES WERE IDENTIFIED ON DEVICE HISTORY REVIEW (DHR), SERVICE HISTORY OR DEATH/SERIOUS INJURY HISTORY MDR REPORT FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death SORIN OXYGENATOR| GISH MPS CARDIOPLEGIA KIT