BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1890782 · Received November 1, 2010

    Report

    Report Number
    1828100-2010-01941
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 1, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER REPORTED THE RUBBER BOOT PROTECTOR ON THE END CONNECTOR WAS TORN. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING 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