BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4535943 · Received February 19, 2015

    Report

    Report Number
    1828100-2015-00108
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE CALLING IN THE COMPLAINT, THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) EXPERIENCED THE SAME ISSUE DURING TROUBLESHOOTING. PER THE FIELD SERVICE REPRESENTATIVE (FSR), THE PERFUSIONIST (CCP) SAID THAT AFTER TIGHTENING THE NUT ON THE BACK OF THE SCREEN, THE REPORTED ISSUE WENT AWAY. THE CCP POWERED UP AND DOWN SEVERAL TIMES, AND WORKED FINE. WHEN THE PROBLEM DID OCCUR AND THE CCM DISPLAY WAS IN THE MAIN SCREEN, THAT BY TOUCHING THE SCREEN THE PROBLEM CORRECTED ITSELF. THE CCP SAID ONCE THE QCU WARMS UP, IT IS FINE. THE CENTRAL CONTROL MONITOR (CCM) ONLY HAS PROBLEMS WHEN FIRST STARTING UP IN THE MORNING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE QUANTUM CONTROL UNIT (QCU) HAD A ROLLING SCREEN. THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REBOOTED AND WIGGLED CABLES A COUPLE OF TIMES, VIDEO STABILIZED. AS A RESULT, AN ALTERNATE PERFUSION SYSTEM WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118671 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 802100

    Patients

    Seq Age Sex Outcome Treatment
    1