BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3915763 · Received June 12, 2014

    Report

    Report Number
    1828100-2014-00467
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 21, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE DATA LOGS WERE RECEIVED BY THE MFR ON (B)(4) 2014 FOR FURTHER EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LARGE ROLLER PUMP SWITCHED OFF TOWARDS THE END OF BYPASS. AN THE END OF OPERATION, THE BIG ROLLER PUMP ON THE SYSTEM-1 IS ALL SWITCHED OFF. THE DOCTOR STATED THE DEVICE WORKED THE WHOLE OPERATION IN A NORMAL MODE AND IN THE END WHEN THEY HAD FINISHED, THEY BEGAN TO REDUCE THE SPEED WITH KNOB ON THE PUMP. WHEN THE USER RETURNED TO THE ZERO POSITION, THE DISPLAY WAS OFF AND WITH A CONFIGURATION ON CENTRAL CONTROL MONITOR (CCM) ON THE PUMP APPEAR A QUESTION MARK. THE USER CHECKED ALL THE CONNECTORS, TOOK THE CABLE FROM ANOTHER PUMP AND PLUGGED IT, BUT NOTHING HAS CHANGED. SINCE THE ACTUAL SURGICAL REPAIR WAS COMPLETED, THERE WAS NO NEED TO CHANGE OUT THE VENT PUMP DURING CPB OR NO NEED FOR ANY OTHER INTERVENTION OF THE VENT PUMP. THE PUMP WAS CHANGED OUT AFTER THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WER NO DELAYS, NO BLOOD LOSS. OR NO ADVERSE CONSEQUENCES TO THE PT. (B)(4) / PER THE CLINICAL REVIEW ON (B)(6) 2014: IN ADDITION, THE SYSTEM-1 LOGS WERE REVIEWED IN ORDER TO UNDERSTAND THE EVENTS OF THIS INCIDENT. A PERFUSION SCREEN WAS OPENED AT 9:53:49. THERE WER NO ISSUES DURING SET-UP OR DURING EARLY PERIODS OF CPB. AT 12:22:10, A LARGE ROLLER PUMP (LABELED AS VENT 2) VENT MISSING FROM THE PERFUSION SCREEN. THE USER DESCRIBED THIS INCIDENT AS THE PUMP LOCAL DISPLAY WENT BLANK AND A "P" MARK APPEARED ON THE CCM (ON VENT 2) PUMP ICON. AT THIS TIME, THE ARTERIAL PUMP FLOW WAS QUITE LOW AND THE OCCLUDED WAS BEING CLOSED. THIS WOULD INDICATE THAT WEANING FROM CPB WAS IN PROCESS AND THUS, THIS OCCURRED IN THE LAST FEW MINUTES OF CPB. SINCE THE ACTUAL SURGICAL REPAIR WAS COMPLETED, THERE WAS NO NEED TO CHANGE OUT THE VENT PUMP DURING CPB OR NO NEED FOR ANY OTHER INTERVENTION OF THE VENT PUMP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM OBSERVED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346799 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816571

    Patients

    Seq Age Sex Outcome Treatment
    1