BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVACED PERFUSION SYSTEM 1

    MDR report key: 3030765 · Received March 27, 2013

    Report

    Report Number
    1828100-2013-00281
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE LARGE ROLLER PUMP WOULD NOT START. THIS PUMP WAS USED AS A SUCTION PUMP. THE SUBSIDIARY CLINICAL ENGINEER TRIED TO START THE PUMP AT THE PERFUSION SCREEN AND THE START/STOP BUTTONS OF CONTROL PANEL, BUT THE PUMP WILL NOT START. AT THIS TIME, PUMP ICONS DISPLAYED WERE NORMAL. (X) OR (?) DID NOT DISPLAY AND THE LOCAL CONTROL PANEL OF PUMP WERE DISPLAYED NORMAL. BUT THE START BUTTON DID NOT WORK. THE CLINICAL ENGINEER CLOSED THE PERFUSION SCREEN, OPENED THE SCREEN AGAIN, AND THEN THE PUMP STARTED TO FUNCTION NORMAL. THEY CONTINUED TO USE THE PUMP AS A VENT PUMP JUST BEFORE THE OPERATION. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124995 TERUMO ADVACED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816571

    Patients

    Seq Age Sex Outcome Treatment
    1