BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1944236 · Received December 6, 2010

    Report

    Report Number
    1828100-2010-02383
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 6, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED A "GAS FLOW OFF" ERROR MESSAGE DISPLAYED ON THE CENTRAL CONTROL MONITOR. THE USER REBOOTED THE SYSTEM AND WAS ABLE TO PERFORM A SUCCESSFUL CALIBRATION; HOWEVER, THE MESSAGE CONTINUED TO DISPLAY. THE USER THEN REPORTED THAT AFTER APPROXIMATELY 20-30 MINUTES WHILE ON BYPASS, THE MESSAGE STOPPED DISPLAYING. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PT AS RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE GAS MODULE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1