BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM ONE

    MDR report key: 3846926 · Received April 5, 2014

    Report

    Report Number
    3846926
    Event Type
    Injury
    Date Received
    April 5, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 2, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BEEN PLACED BACK ON BYPASS DURING CABG DUE TO SUDDEN CHANGE IN CARDIAC STATUS. SHORTLY AFTER BYPASS INITIATED, AIR WAS NOTED IN THE ARTERIAL CIRCULATION OF THE PUMP CIRCUIT. SOURCE OF AIR UNKNOWN. BYPASS WAS STOPPED AND PROTOCOLS FOLLOWED IN AN EFFORT TO EVACUATE AIR. BYPASS WAS THEN RE-INITIATED AND PROCEDURE CONTINUED WITH PATIENT SUCCESSFULLY TAKEN OFF BYPASS. POST-OP, PATIENT UNABLE TO RESPOND TO COMMANDS AND HAS NO PURPOSEFUL MOVEMENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205603 TERUMO ADVANCED PERFUSION SYSTEM ONE CARDIOPULMONARY BYPASS MACHINE DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability MEDTRONIC DLP 753202 STRAIGHT TIP 20F ARTERIAL| TERUMO CARDIOVASCULAR PROCEDURE KIT: (B)(4)| VENOUS CANNULA| CANNULA| EDWARDS LIFESCIENCES TR 3240L 2-STAGE VENOUS 32/40| TERUMO OXYGENATOR: #535913K