BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3221856 · Received July 9, 2013

    Report

    Report Number
    1828100-2013-00645
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP (FSR) WAS UNABLE TO VERIFY STATED ISSUE. THE PERFUSIONIST (CCP) MENTIONED HE HAD PERFORMED A SCREEN CALIBRATION AFTER THE ISSUE AND PREVIOUSLY BEFORE THIS INCIDENT BUT THE MONITOR WOULD COME OUT OF CALIBRATION. THE FSR INSTALLED AND CONFIGURED A SERVICE LOANER MONITOR, AND PERFORMED FUNCTIONAL TESTING. THE LOANER UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT DEVICE WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE TOUCH SCREEN WAS NOT RESPONSIVE ON THE CENTRAL CONTROL MONITOR (CCM). THE CURSOR WAS ALSO OUT OF ALIGNMENT (IT WAS AROUND AN INCH HIGHER THAN WHERE CUSTOMER WANTED TO SELECT ON THE SCREEN). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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
    312882 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 802100

    Patients

    Seq Age Sex Outcome Treatment
    1