BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 3979772 · Received July 2, 2014

    Report

    Report Number
    1828100-2014-00560
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K902198
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE FIELD SERVICE REPRESENTATIVE (FSR) VERIFIED THE CUSTOMER HAD THE CENTRIFUGAL SYSTEM CONNECTED TOT HE ALARM OUTLET AN THE BATTERIES WERE DISCHARGED FULLY. THE FSR REPLACED THE BATTERIES. DURING THE BATTERY REPLACEMENT AND PREVENTATIVE MAINTENANCE (PM), THE FSR FOUND THE CHARGE METER ON THE BATTERY MODULE WOULD STICK INTERMITTENTLY (SEE MDR #182810-2014-00577). THE FSR COMPLETED THE PM AND THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT BATTERIES WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL PUMP DID NOT RUN ON BATTERY AS IT SHOULD HAVE. THE BATTERY SHOWED FULLY CHARGED, BUT IT WAS DEAD. POWER WAS LOST TO THE PUMP AND THE BATTERY DID NOT KICK ON. THE DEVICE WAS NOT CHANGED OUT, AS THE CUSTOMER RESET THE UNIT AND POWER WAS RESTORED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW ON (B)(6) 2014: TOWARDS THE END OF CPB, THE VENOUS RESERVOIR WAS LOW IN FLUID LEVEL AND THE PERFUSIONIST (CCP) ADDED SOME CRYSTALLOID SOLUTION TO THE RESERVOIR SO THE ARTERIAL BLOOD FLOWS COULD BE MAINTAINED AT THE REASONABLE LEVEL TO ADEQUATELY SUPPORT THE CIRCULATION. SHORTLY AFTER THE SOLUTION WAS ADDED, THE AIR BUBBLE DETECTOR (ABD) ALARMED AND THE CENTRIFUGAL PUMP LOST POWER. THIS BEHAVIOR WAS NOT CONSISTENT WITH HOW THE SYSTEM WAS CONFIGURED. THE CENTRIFUGAL CONTROL MODULE WAS CONNECTED TO A DELPHIN BATTERY AND THE BATTERY WAS IN THE CONNECT MODE. WITH THIS CONFIGURATION, AN ABD ALARM DOES CUT POWER TO THE CENTRIFUGAL CONTROL MODULE, BUT THE DELPHIN BATTERY (IN THE CONNECT MODE) SHOULD AUTOMATICALLY KEEP THE CONTROL MODULE POWERED UP AND THIS WOULD MAINTAIN ALL FUNCTIONS; MOTOR FUNCTION, FLOW MEASUREMENT, AND ALL COMMUNICATIONS AND MESSAGING FUNCTIONS). SINCE THE CONTROL MODULE LOST POWER, ARTERIAL BLOOD FLOW WAS STOPPED. THE CCP CLAMPED THE ARTERIAL AND VENOUS LINES AND REMOVED THE CENTRIFUGAL PUMP HEAD FROM THE MOTOR AND PLACED THE PUMP HEAD INTO A MANUAL DRIVE (HAND CRANK). THE CCP STARTED TO HAND CRANK AND UNCLAMPED AND ARTERIAL LINE AND VENOUS LINE TO PROVIDE ARTERIAL BLOOD FLOW. AS THE CCP WAS HANDCRANKING, HE TURNED OFF THE AIR BUBBLE DETECTOR (ON THE SAFETY MONITOR) AND A/C POWER WAS RESTORED TO THE CONTROL MODULE. THE CCP CLAMPED THE ARTERIAL AND VENOUS LINES AND MOVED THE CENTRIFUGAL PUMP HEAD FROM THE MANUAL DRIVE BACK TOT HE DRIVE MOTOR. THE DRIVE MOTOR WAS STARTED AND CLAMPS WERE REMOVED AND ARTERIAL FLOW WAS AGAIN PROVIDED BY THE CONTROL MODULE AND DRIVE MOTOR. THERE WERE NO OTHER ISSUES THE REMINDER OF THE CPB AND THE PATIENT WAS WEANED FROM CPB WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ASSOCIATED BLOOD LOSS. ARTERIAL FLOW WAS LOST FOR ABOUT FIFTEEN SECONDS AS THE INCIDENT WAS TROUBLESHOOTED AND HAND CRANKING WAS ESTABLISHED. ACCORDING TO THE CCP, HANDCRANKING WAS PERFORMED FOR ABOUT THIRTY TO SIXTY SECONDS AND THEN THE CONTROL MODULE WAS RE-BOOTED AND USED FOR THE REMAINDER OF CPB. THERE WAS NO INTERRUPTION OF THE SURGICAL PROCEDURE DURING THESE EVENTS (CV SURGEON CONTINUED TO OPERATE) AND THUS THERE WAS NO DELAY IN THE ACTUAL SURGICAL PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE ICU, PER PROTOCOL, AFTER THE PROCEDURE AND THE PATIENT WAS AWAKE, ALERT, AND RESPONDING TO COMMANDS WITHIN A FEW HOURS. THERE WAS NO HARM OBSERVED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387680 TERUMO CENTRIFUGAL SYSTEM SARNS CENTRIFUGAL SYSTEM KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 9490

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention