BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 5999483 · Received October 5, 2016

    Report

    Report Number
    1828100-2016-00659
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 11, 2016
    Report Date
    May 31, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K151349
    Removal / Correction Number
    1828100-06/05/2007-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) COULD NOT DUPLICATE ANY ISSUES WITH THE SYSTEM DURING EXTENDED TESTING. THE DATA LOGS HAVE AN "EVENT" NOTED BUT CANNOT PINPOINT AN ISSUE. THE FSR PERFORMED A PREVENTATIVE MAINTENANCE, THE SYSTEM MET MANUFACTURERS SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE USER FACILITY IS GOING TO DELEGATE THIS MACHINE AS A BACK-UP ONLY UNTIL THE FSR RETURNS TO REPLACE THE CENTRAL CONTROL MONITOR, WHEN AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. PER DATA LOG ANALYSIS: THE CENTRIFUGAL LOG GOES ALL THE WAY BACK TO 7-AUG-2016, AND THE SYSTEM WAS LEFT POWERED ON UNTIL AT LEAST 11-SEP-2016 (NEVER POWERED DOWN). ON 11-SEP-2016 AT 9:00 PM THE CENTRAL CONTROL MONITOR (CCM) WAS NO LONGER COMMUNICATING WITH THE CENTRIFUGAL, THE PUMP LOGGED "QCU MISSING". THE SYSTEM LOG ONLY WENT BACK TO 9:19:49 PM AND WAS LOGGING "ERROR QUEUE GUI OVERFLOW", "ERROR CRITICAL QUEUE OVERFLOW", "ERROR PROCESS GUI DIED", AND "ERROR CRITICAL PROCESS DIED" OVER AND OVER. THE CCM LOG DID NOT GO BACK FAR ENOUGH TO SHOW WHAT LED INTO THE ERROR CONDITION.THE SYSTEM IS POWER CYCLED ON 12-SEP-2016, AND ALL SEEMS NORMAL NOW. THERE IS NO WAY TO TELL FROM THE LOG WHAT THE DISPLAY ON THE CCM WAS DOING. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED THE CCM TO FUNCTION PROPERLY WITH NO BURNED LOOKING SCREEN OBSERVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAY WAS "NOT NORMAL" WITH A "BURNED LOOKING" SCREEN "OVER" THE REGULAR SCREEN. THE PERFUSIONIST REMOVED THE DEVICE IN QUESTION AND REPLACED THE ENTIRE MACHINE WITH THEIR SPARE AND MOVED THE DISPOSABLES FROM THE MACHINE IN QUESTION TO THE REPLACEMENT MACHINE. THE PRODUCT WAS CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652172 TERUMO ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1