BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6136821 · Received November 30, 2016

    Report

    Report Number
    1828100-2016-00769
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 8, 2016
    Report Date
    February 23, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K153376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. 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

    (B)(4). ADDITIONAL INFORMATION PROVIDED BY THE CHIEF PERFUSIONIST INCLUDED THAT DURING THE EVENT, NO AUDIBLE TONES WERE HEARD, THERE WAS NO LOSS OF FLOW, AS VERIFIED BY THE COMPUTER SCREEN. THEY DID NOT HAVE TO COME OFF BYPASS AND DID NOT HAVE TO HAND CRANK AS FLOW WAS NOT DISRUPTED. ONLY THE PUMP MODEL SCREEN WENT BLANK FOR ABOUT 30 SECONDS. THERE WERE NO ERRATIC RPMS AND NO BACK FLOW. THE DISPLAY AND MONITOR ARE CURRENTLY WORKING. BOTH CONNECTORS AT THE BACK OF THE CONTROLLER MODULE APPEARED TO BE FULLY ENGAGED. PER FIELD SERVICE REPRESENTATIVE (FSR), HE CHECKED AND STRESSED POWER CABLE TO CENTRIFUGAL CONTROLLER. ALL CONNECTORS WERE CHECKED, AND THE UNIT WAS OPENED UP. CONNECTOR WAS PUSHED TO DISPLAY BOARD SLIGHTLY TO MAKE A TIGHTER CONNECTION. LOGS WERE DOWNLOADED AND TECHNICAL SUPPORT REPRESENTATIVE (TSR) ANALYZED LOGS AND FOUND NO EVIDENCE INDICATING THAT DISPLAY WENT BLANK. BLANK SCREEN IS USUALLY CAUSED BY THE SMALL DISPLAY ASSEMBLY OR A CONNECTION TO THE DISPLAY. UNIT PASSED RELEASE TEST AND MEETS SPECIFICATIONS. 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 USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE SCREEN OF THE CENTRIFUGAL CONTROL UNIT WENT BLACK OUT FOR 10 SECONDS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: PERFUSIONIST REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB), THE DISPLAY OF THE CENTRIFUGAL CONTROL MODULE (CCM) BLANKED. THE MOTOR CONTINUED TO OPERATE AND THE DESIRED BLOOD FLOW WAS ABLE TO BE MAINTAINED. PERFUSIONIST "JIGGLED" THE POWER CABLE IN BACK OF THE MODULE AND THE DISPLAY RETURNED TO USUAL FUNCTION. THE DISPLAY WAS BLANK FOR ABOUT 10 SECONDS. THERE WERE NO OTHER ISSUES, THE REMAINDER OF THE PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787944 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816572

    Patients

    Seq Age Sex Outcome Treatment
    1