BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1872328 · Received October 12, 2010

    Report

    Report Number
    1828100-2010-01736
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 12, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE, PRIOR TO THE ONSET OF CARDIOPULMONARY BYPASS, THE USER REPORTED THE CIRCUIT BREAKER TRIPPED. THE USER ACCIDENTALLY PLUGGED A 100V SYSTEM INTO A 200V POWER SOURCE. THE PT WAS ANESTHETISED AND THE STERNOTOMY HAD BEEN PERFORMED. THE PT'S CHEST WAS CLOSED THE PT WAS TRANSFERRED TO ICU. THE USER REPORTED THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED ON (B)(6), 2010 NOT (B)(6), 2010, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1