BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3603081 · Received January 23, 2014

    Report

    Report Number
    1828100-2014-00021
    Event Type
    Death
    Date Received
    January 23, 2014
    Date of Event
    January 4, 2014
    Report Date
    January 4, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFUSIONIST MANUALLY HAND CRANKED FOR AROUND TEN MINUTES, ASKED A NURSE TO ASSIST HIM WITH HAND CRANKING, THEN PROCEEDED TO SHUT THE SYSTEM ONE DOWN AND REBOOT THE SYSTEM. ONCE THE SYSTEM WAS BACK UP, THE PERFUSIONIST DETERMINED THE CENTRIFUGAL DRIVE MOTOR WAS WORKING, SO HE REINSERTED THE CENTRIFUGAL HEAD INTO THE DRIVE MOTOR AND FINISHED THE CASE. THE PT'S PRESSURE RESPONDED APPROPRIATELY AS DID HIS RESERVOIR VOLUME. THE FIELD SERVICE REPRESENTATIVE (FSR) STATED THAT THE FILTERS WERE VERY DIRTY. HE CHANGED THE FILTERS ON THE UNIT PER REQUEST FROM HOSPITAL. THE FSE DOSE NOT HAVE THE FILTERS TO RETURN, AS THE FSR DOES NOT HAVE THE FILTERS TO RETURN, AS THE FSR TURNED THEM OVER TO HOSPITAL VP. THE FSR DOWNLOADED THE SYSTEM-1 LOGS ON (B)(4) 2014. MULTIPLE BACK FLOWS WERE RECORDED IN THE LOGS. THE LOGS ALSO DETAIL THAT AN ABD (AIR BUBBLE DETECTOR) WAS NOT CONFIGURED AND THUS NOT USED DURING CPB AND THAT A LEVEL SENSOR WAS CONFIGURED, BUT NEVER ACTIVATED FOR THE PROCEDURE. THE PROCEDURE USED A VACUUM ASSISTED VENOUS DRAINAGE (VAVD) AND WITH CHANGING PT RESISTANCE DUE TO VASOPRESSOR THERAPY (LARGE DOSES OF NEOSYNEPHRINE AND LEVOPHED), A SPEED OF 1500RPMS COULD RESULT IN A BACK FLOW ALARM. REVIEW OF THE DATA LOGS, DETAILS THE PERFUSION SYSTEM (SYSTEM 1) WAS SETUP ON (B)(4) 2014 AND THE CENTRIFUGAL DRIVE MOTOR WAS SPINNING AT APPROXIMATELY 1700PMS DURING THE TWO DAY PERIOD. THE PERFUSIONIST CONFIRMED THE PUMP HEAD, CPB CIRCUIT AND PERFUSION SYSTEM WAS USED ON THE CASE ON (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PERFUSIONIST (CCP) NOTICED A DECREASE IN FORWARD FLOW LEADING TO A REVERSE FLOW ALARM, BUT THE REVOLUTIONS PER MINUTE (RPMS) REMAINED CONSTANT. AT THIS TIME, THE CCP BEGAN TROUBLESHOOTING THE FLOW PROBE AND CENTRIFUGAL HEAD. ALL SEEMED TO BE WORKING APPROPRIATELY. WHEN THE PT'S PRESSURE BEGAN TO DROP AND HIS RESERVOIR VOLUME BEGAN INCREASING, THE PERFUSIONIST CLAMPED OUT HIS VENOUS LINE AND CENTRIFUGAL HEAD, REMOVED IT FROM THE DRIVE MOTOR, INSERTED IT INTO THE MANUAL HAND CRANK, REMOVED CLAMPS AND REESTABLISHED FORWARD FLOW. THE PT WAS TRANSFERRED TO THE ICU PER ROUTINE PRACTICE. DURING RECOVER, THE PT WAS DIAGNOSED AS HAVING SUFFERED A STROKE. THE PT EXPIRED ON (B)(6) 2014. PER THE CLINICAL REVIEW ON (B)(6) 2014: AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACE PRIOR TO PROVIDE CIRCULATING ASSISTANCE. CABG WAS PERFORMED WITH CPB, BUT WAS PERFORMED WITH A BEATING HEAT AND THUS NO AORTIC CROSS-CLAMP WAS APPLIED AND NO CARDIOPLEGIA WAS ADMINISTERED. ABOUT SEVENTY-EIGHTY MINUTES INTO CPB, A BACK FLOW ALARM WAS EXPERIENCED. THE BACK FLOW ALARM WAS CLOSELY FOLLOWED WITH FILLING OF THE VENOUS RESERVOIR AND DROPS IN PT AND CPB CIRCUIT PRESSURE. THE CCP QUICKLY TROUBLESHOOTED THE EVENTS AND HE ELECTED TO REMOVE THE CENTRIFUGAL PUMP HEAD FROM THE MOTOR AND BEGAN TO HAND CRANK THE PUMP HEAD TO PROVIDE CIRCULATORY SUPPORT. A PROCEDURE DELAY OF ABOUT ONE MINUTE WAS EXPERIENCED AS TROUBLESHOOTING STEPS WERE BEING CONSIDERED. AN ADDITIONAL FORTY-EIGHT BACK FLOW ALARMS OCCURRED DURING HAND CRANKING OF THE PUMP HEAD (AS DOCUMENTED IN SYSTEM-1 LOGS). ACCORDING TO THE CCP, THE PT BLOOD PRESSURE WAS MAINTAINED AT ABOUT 25-35 MMHG DURING THE HAND CRANKING. AFTER EIGHT MINUTES OF HAND CRANKING, THE CCP ASKED A NURSE TO HELP WITH HAND CRANKING AND THE CCP EXITED THE PERFUSION SCREEN AND RE-ENTERED THE SAME PROGRAM. THE PUMP HEAD WAS REMOVED FROM THE HAND CRANK AND PLACE BACK IN THE CENTRIFUGAL MOTOR. THE MOTOR WAS STARTED AND WAS ABLE TO BE INCREASED TO LEVELS GREATER THAN 2000 RPM AND ARTERIAL FLOW WAS RETURNED TO DESIRED LEVELS. THE TOTAL HAND CRANKING TIME WAS TEN MINUTES. AFTER RETURN TO THE PERFUSION SCREEN, THE REMAINDER OF CPB WAS WITHOUT INCIDENT. THE CASE WAS COMPLETED, AS SCHEDULED. THERE WAS NO LOSS OF BLOOD ASSOCIATED WITH THESE EVENTS. THE PT WAS TRANSFERRED TO ICU PER ROUTINE PRACTICE. DURING THE ICU STAY, THE PT WAS DIAGNOSED TO HAVE SUFFERED A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54869 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CENTRIFUAL DRIVE) DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 164267

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death DISPOSABLE DELPHIN CENTRIFUGAL PUMP HEAD