BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3072588 · Received April 18, 2013

    Report

    Report Number
    1828100-2013-00359
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 29, 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

    Additional Manufacturer Narrative · 1

    PER THE MANUFACTURING ENGINEERING CENTER (MEC), THERE WAS TIME LAG BETWEEN THE ALARM AND THE ERROR MESSAGE OF ABOUT ONE MINUTE. SOFTWARE DATA LOGS WERE SENT TO THE MFR FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ULTRASONIC LEVEL SENSOR ALARMED WITHOUT CAUSE AND WITHOUT ERROR MESSAGES ON CENTRAL CONTROL MONITOR (CCM). AFTER ONE MINUTE, "NOT ATTACHED" MESSAGE WAS DISPLAYED ON CCM. AT THIS TIME, THEY WERE NOT ABLE TO CONFIRM THAT THE LEVEL SENSOR WAS NOT MOUNTED TO VENOUS RESERVOIR. 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 PATIENT. PER ADDITIONAL INFORMATION FROM THE CUSTOMER: THE AUDIBLE ALARM WAS SOUNDED CONTINUOUSLY FOR ONE MINUTE WITHOUT ANY MESSAGE. AFTER ONE MINUTES LATER, "LEVEL SENSOR NOT ATTACHED" ALARM WAS DISPLAYED ON CCM MESSAGE AREA AND LEVEL ICON TURN FROM GREEN TO READ (OR YELLOW). THERE FORE, THE CUSTOMER TOOK THE SENSOR OFF AN PUT A GEL AND REATTACHED THE SENSOR THE RESERVOIR, AFTER THAT THE AUDIBLE ALARM WAS GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168518 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195274

    Patients

    Seq Age Sex Outcome Treatment
    1