BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2153123 · Received June 17, 2011

    Report

    Report Number
    1828100-2011-01721
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 17, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT WHEN THE SYSTEM-1 BOOTED UP, IT POWERED UP IN THE DC BATTERY MODE EVEN THOUGH THE SYSTEM WAS PLUGGED INTO AN AC OUTLET. THE SYSTEM WAS RE-BOOTED, PLUGGED INTO ANOTHER AC OUTLET, AND AGAIN CAME UP IN THE DC BATTERY MODE. AFTER A 10-15 DELAY, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED, THE SURGICAL PROCEDURE COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1