BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 5098045 · Received September 23, 2015

    Report

    Report Number
    1828100-2015-00818
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    July 10, 2015
    Report Date
    September 23, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Removal / Correction Number
    1828100-06/05/2007-011-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS RELATED TO MEDWATCH #1828100-2015-00655. THE REPORTED COMPLAINT WAS CONFIRMED. DURING LABORATORY EVALUATION THE COMPLAINT WAS DUPLICATED. THE PRODUCT SURVEILLANCE TECHNICIAN (PST) CONNECTED THE CENTRIFUGAL CONTROL UNIT (CCU) TO SYSTEM-1 POWER SUPPLY AND POWERED ON. HE OBSERVED NO DISPLAY ON PUMP MODULE. THE PST DISASSEMBLED THE CCU AND INSPECTED ALL CONNECTIONS. ALL CONNECTORS HAVE FIRM ROBUST CONNECTIONS. THE PST REAPPLIED POWER TO THE CCU AND OBSERVED NO DISPLAY. HE POWERED OFF DEVICE UNDER TEST (DUT) CCU. IT WAS DETERMINED THAT A GRAPHICS DRIVER BOARD (PART NUMBER 801520) WAS RELATED TO THE DISPLAY FAILURE. THE DEVICE WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURERS SPECIFICATIONS BEFORE BEING RETURNED TO THE CUSTOMER. 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

    DURING INVESTIGATION OF PARENT COMPLAINT REPORTED ON MEDWATCH 1828100-2015-00655 WHERE AFTER CARDIOPULMONARY BYPASS THE CENTRIFUGAL PUMP CONTROL MODULE WAS DEAD, IT WAS DETERMINED THE DISPLAY FAILURE OF THE CENTRIFUGAL CONTROL MODULE WAS SEPARATE FROM THE POWER LOSS. THEREFORE AN ADDITIONAL COMPLAINT WAS CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629051 TERUMO ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED SYSTEM DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801046

    Patients

    Seq Age Sex Outcome Treatment
    1