BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1920973 · Received November 11, 2010

    Report

    Report Number
    1828100-2010-02045
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 5, 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
    TC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE ARTERIAL PRESSURE MEASUREMENT FAILED TO BE DISPLAYED. THE USER REPORTED THAT THE WIDE BAND PRESSURE TRANSDUCER WAS FOUND TO BE DEFECTIVE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR 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 PRESSURE TRANSDUCER DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 16433301

    Patients

    Seq Age Sex Outcome Treatment
    1