BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1840643 · Received September 17, 2010

    Report

    Report Number
    1828100-2010-01489
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 17, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE HEART LUNG CONSOLE GENERATED AN AUDIBLE ALARM AND NO ERROR MESSAGE WAS VISIBLE INDICATING THE REASON FOR THE ALARM. THE USER REPORTED THE ALARM WAS INTERMITTENT IN NATURE. THE USER ALSO REPORTED THIS SAME ISSUE HAD OCCURRED APPROXIMATELY TWO OTHER TIMES. THE DEVICE WAS USED TO CONCLUDE THE PROCEDURE. 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 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 801763

    Patients

    Seq Age Sex Outcome Treatment
    1