BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1920988 · Received November 11, 2010

    Report

    Report Number
    1828100-2010-02042
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 11, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE LOCAL DISPLAY OF THE CENTRIFUGAL CONTROL UNIT WAS FLICKERING. THE USER TAPPED ON THE DEVICE, AND THE DISPLAY APPEARED AND STOPPED FLICKERING. THIS FAILURE WAS INTERMITTENT IN NATURE. THE DEVICE WAS USED FOR THE PROCEDURE, AS THE CENTRAL CONTROL MONITOR STILL DISPLAYED THE APPROPRIATE INFO, EVEN WITH THE FLICKERING DISPLAY OF THE CENTRIFUGAL CONTROL UNIT. THE USER REPORTED THE SURGICAL PROCEDURE WAS 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 CENTRIFUGAL CONTROL UNIT DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801046

    Patients

    Seq Age Sex Outcome Treatment
    1