BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1935716 · Received December 3, 2010

    Report

    Report Number
    1828100-2010-02350
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 3, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE PUMP STOPPED AND A "MOTOR DISCONNECTED" MESSAGE APPEARED. THE USER ATTEMPTED TO RESTART, AND THE MOTOR WOULD ROTATE, BUT THEN STOP AND DISPLAY AN "OVERSPEED" ERROR MESSAGE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL DRIVE MOTOR DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 164267

    Patients

    Seq Age Sex Outcome Treatment
    1