BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2915420 · Received January 9, 2013

    Report

    Report Number
    1828100-2012-01627
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE DISPLAY ON THE CENTRIFUGAL CONTROLLER BLANKED OUT. THERE WAS A MESSAGE ON THE CENTRAL CONTROL MONITOR THAT THE CENTRIFUGAL MOTOR WAS IN ¿COAST MODE¿. THE DEVICE WAS NOT CHANGED OUT AS A CENTRIFUGAL STAND ALONE UNIT WAS READY FOR USE IF NEEDED. THE CASE WAS CONTINUED WITH CAUTIONARY MEASURES. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12687 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801046

    Patients

    Seq Age Sex Outcome Treatment
    1