BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2960677 · Received January 25, 2013

    Report

    Report Number
    1828100-2013-00073
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 9, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP (FSR) COULD NOT DUPLICATE THE REPORTED ISSUE. INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE PERFUSIONIST (CCP) NOTICED THE ARTERIAL AND THE CARDIOPLEGIA PUMPS HAD STOPPED. THE CCP SWAPPED THE ARTERIAL PUMP WITH THE SUCKER PUMP (SWAPPED TUBING AND TUBING INSERTS AS WELL). THERE WAS A DELAY OF ABOUT ONE AND A HALF MINUTES OF LOST ARTERIAL FLOW. NO ALARMS WERE SEEN OR HEARD ON EITHER PUMP STOP. THE CCP WAS ABLE TO PLACE THE PUMP IN THE START MODE AND WAS ABLE TO DELIVER CARDIOPLEGIA, AS NEEDED, FOR THE REMAINDER OF THE PROCEDURE. THE LOSS OF THE CARDIOPLEGIA PUMP DID NOT DELAY THE DELIVERY OF CARDIOPLEGIA. THE REMAINDER OF CPB WAS WITHOUT ISSUE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35525 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1