BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2040872 · Received March 21, 2011

    Report

    Report Number
    1828100-2011-00664
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 21, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE CENTRIFUGAL PUMP STOPPED DUE TO THE AIR BUBBLE DETECTOR ALARM. SHORTLY AFTER THE INITIATION OF CARDIOPULMONARY BYPASS (6 MINUTES INTO PROCESS), THE VENOUS RESERVOIR DRAINED AND AIR ENTERED THE CENTRIFUGAL PUMP HEAD. THE AIR SENSOR ACTIVATED AND STOPPED THE ARTERIAL PUMP, AS CONFIGURED. THE (B)(6) STRUGGLED TO RE-SET THE AIR SENSOR AND THE ARTERIAL PUMP WAS NOT ABLE TO BE RE-STARTED (SINCE AIR ALARM WAS NOT RE-SET). THE (B)(6) BEGAN TO HAND CRANK AND THIS CONTINUED FOR 4-5 MINUTES, WITH THE PATIENT BLOOD TEMPERATURE AT 33 DEGREES C. DURING HAND CRANKING THE REGIONAL CEREBRAL SATURATIONS DROPPED FROM A BASELINE OF 61% TO 48%. THE (B)(6) WAS ABLE TO RE-SET THE AIR SENSOR AND RE-START CARDIOPULMONARY BYPASS, AFTER THE 4-5 MINUTES OF HAND CRANK SUPPORT. AFTER CARDIOPULMONARY BYPASS WAS RE-STARTED, BLOOD FLOWS, PRESSURES, AND SATURATIONS RETURNED QUICKLY TO BASELINE LEVELS. THERE WAS A DELAY OF 5 MINUTES IN THE SURGICAL PROCEDURE, BUT THE PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WAS NO LOSS OF BLOOD AND THERE WAS NO OBSERVED HARM OF THE PATIENT. THE FIELD SERVICE REPRESENTATIVE TESTED THE MACHINE AND COULD NOT DUPLICATE THE PROBLEM WITH CUSTOMER IN ATTENDANCE. THE DEVICE WAS USED FOR THE REMAINDER OF THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1