BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1791574 · Received August 6, 2010

    Report

    Report Number
    1828100-2010-01095
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 6, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED HORIZONTAL LINES APPEARED INTERMITTENTLY ON THE SCREEN OF THE CENTRAL CONTROL MONITOR. THE DEVICE WAS USED 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 CENTRAL CONTROL MONITOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 802100

    Patients

    Seq Age Sex Outcome Treatment
    1