BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC PERFUSION CANNULA

    MDR report key: 6167894 · Received December 12, 2016

    Report

    Report Number
    3008500478-2016-00040
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 18, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K123370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT WAS DISCARDED BY HOSPITAL STAFF. MANUFACTURING RECORDS WERE UNABLE TO BE REVIEWED AS NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION RECEIVED, A MANUFACTURING RELATED ISSUE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, OPERATIONAL CONTEXT MOST LIKELY CONTRIBUTED TO THIS EVENT. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE USE OF EDWARDS QUALITY SYSTEMS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS WAS NOTIFIED THAT A PATIENT SUSTAIN AN AORTIC INJURY. AN EDWARDS CANNULA WAS PUSHED INTO THE AORTOTOMY SITE TOO FAR AND THE INCISION SITE WAS REPAIRED. THE PATIENT WAS STABLE FOLLOWING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817247 AORTIC PERFUSION CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES ARS020CS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other