BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1970035 · Received January 14, 2011

    Report

    Report Number
    1828100-2010-02897
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 14, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 VOLUME INDICATOR FAILED. THE FIELD SERVICE REPRESENTATIVE FOUND OUT THE PERFUSIONIST HAD THE PUMP SET UP ON RPM AND NEEDED TO BE SET ON S4:1 IN ORDER FOR IT TO CALCULATE VOLUME. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 CARDIOPLEGIA MONITOR JOR TERUMO CARDIOVASCULAR SYSTEMS CORP 16414

    Patients

    Seq Age Sex Outcome Treatment
    1