BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PEFUSION SYSTEM 1

    MDR report key: 1890168 · Received October 22, 2010

    Report

    Report Number
    1828100-2010-01838
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 22, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE SPEED CONTROL WAS NOT WORKING PROPERLY. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PEFUSION SYSTEM 1 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816571

    Patients

    Seq Age Sex Outcome Treatment
    1