BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ GLIDE AORTIC CANNULA

    MDR report key: 3941747 · Received July 17, 2014

    Report

    Report Number
    3008500478-2014-00107
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K123370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Additional Manufacturer Narrative · 1

    EDWARDS RECEIVED INFORMATION THAT DURING THE USE OF AN EZ GLIDE THE PRODUCT WOULDN'T VENT. THE PRODUCT WAS RETURNED FOR EVALUATION. THE CLINICAL OBSERVATION WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THERE WAS DRIED BLOOD INSIDE THE VENT CAP THAT APPEARED TO OCCLUDE THE PLUG. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED. THE ROOT CAUSE OF THE WAS THE VENT PLUG BECOMING WET (BLOOD) PRIOR TO USE. THE INSTRUCTIONS FOR USE (IFU) NOTE TO KEEP THE VENT PLUG DRY PRIOR TO USE. THE POROUS VENT PLUG IS DESIGNED TO VENT AIR WHEN DRY AND MAY NOT FUNCTION AS INTENDED IF WET. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO RELATED NON-CONFORMANCES FOUND. NO CAPA IS APPLICABLE AT THIS TIME. THE INSTRUCTIONS FOR USE, TRAINING, AND RISK CONTROL MEASURES ARE APPROPRIATE AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS QUALITY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF AN EZ GLIDE AORTIC CANNULA THAT THE PRODUCT WOULD NOT VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418847 EZ GLIDE AORTIC CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES EZC21TA 59418160

    Patients

    Seq Age Sex Outcome Treatment
    1