BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3896492 · Received May 16, 2014

    Report

    Report Number
    1828100-2014-00365
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL SENSOR WAS FALSE ALARMING. THE DEVICE WAS NOT CHANGED OUT, AS THEY TURNED OFF THE ALARM. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW ON (B)(6) 2014: PER THE PERFUSIONIST (CCP), A LOW LEVEL ALARM OCCURRED DURING CPB IN SPITE OF ADEQUATE BLOOD LEVEL IN THE VENOUS RESERVOIR. THE ARTERIAL ROLLER PUMP STOPPED PER DESIGN OF THE SYSTEM. THE CCP TRIED TO CLEAR (RESET) THE ALARM, BUT WAS UNABLE. THE CCP TURNED OFF THE LEVEL SENSOR, RESTARTED THE ARTERIAL PUMP, AND RETURNED TO CPB. THE ARTERIAL PUMP WAS OFF FOR ABOUT TEN SECONDS. AFTER THE RETURN TO CPB, THE CCP CHANGED THE LEVEL SENSOR MODE (ON THE BACK OF THE SAFETY MONITOR) TO ALERT ONLY AND HE TURNED ON THE ALERT LEVEL SENSOR AND USED THE ALERT SENSOR THE REMAINDER OF THE PROCEDURE. THIS DID NOT DELAY THE PROCEDURE AND THE TEN SECOND LOSS OF ARTERIAL FLOW HAD NO CLINICAL IMPACT IN THE ABILITY TO PROVIDE ADEQUATE PERFUSION. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT OBSERVED OR REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294539 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195274

    Patients

    Seq Age Sex Outcome Treatment
    1