BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA

    MDR report key: 1981590 · Received January 31, 2011

    Report

    Report Number
    1828100-2011-00069
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 31, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PRIMING IN PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE BLUE CAP ON THE CANNULA FELL OFF WHEN OPENING PACKAGE. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA CANNULA AND CATHETER DWF TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 4949 0620740

    Patients

    Seq Age Sex Outcome Treatment
    1