BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 2181050 · Received July 1, 2011

    Report

    Report Number
    1828100-2011-01827
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THAT THE MOTOR HAD EXCESSIVE VIBRATION WHEN RUNNING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THAT 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 CENTRIFUGAL SYSTEM CENTRIFUGAL CONTROL MODULE DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 164267

    Patients

    Seq Age Sex Outcome Treatment
    1