BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1925870 · Received November 8, 2010

    Report

    Report Number
    1828100-2010-02033
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 8, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE OCCLUDER MODULE WOULD RESET ITSELF. THE USER ATTEMPTED TO RECALIBRATE THE DEVICE, BUT THE ATTEMPT FAILED. THE USER WAS ABLE TO CLAMP MANUALLY, AND THE DEVICE WAS USED TO CONCLUDE THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, 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 (OCCLUDER MODULE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 803480

    Patients

    Seq Age Sex Outcome Treatment
    1