BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ARTERIAL CANNULA

    MDR report key: 1022217 · Received March 26, 2008

    Report

    Report Number
    1828100-2008-00201
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K930620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    THE USER OBSERVED THE STIFFNESS OF THE CANNULA TUBING DIFFERENT THAN NORMAL AND EXPRESSED CONCERN THAT THE VARIABILITY COULD RESULT IN POTENTIAL ADVERSE CONSEQUENCES WHEN INSERTED INTO THE AORTA. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ARTERIAL CANNULA ARTERIAL CANNULA DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. L7350 2120685

    Patients

    Seq Age Sex Outcome Treatment
    1