BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER AND CANNULA

    MDR report key: 3060648 · Received April 5, 2013

    Report

    Report Number
    1828100-2013-00322
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS A LEAK FROM THE MAIN BODY OF THE 7MM SOFT FLOW ANGLED ARTERIAL CANNULA. AFTER AORTIC CROSS-CLAMPING, THE SEGMENT CLAMPED WITH FORCEPS WAS BROKEN AND BLOOD LEAKED. IT MAY HAVE BEEN CLAMPED AT THE BASE OF THE FORCEPS. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139839 CATHETER AND CANNULA DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 6392

    Patients

    Seq Age Sex Outcome Treatment
    1