BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 2172491 · Received June 24, 2011

    Report

    Report Number
    1828100-2011-01778
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 CENTRIFUGAL CONTROL MODULE DISPLAY WENT BLANK FOR ABOUT 20 MINUTES AND THEN CAME BACK ON. THE MOTOR DID NOT STOP. 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 CENTRIFUGAL SYSTEM CONTROLLER UNIT DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 816572

    Patients

    Seq Age Sex Outcome Treatment
    1