BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA VENT CAP

    MDR report key: 1844319 · Received September 24, 2010

    Report

    Report Number
    1713910-2010-00268
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 24, 2010
    Report Date
    November 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VENT CAP FAILED TO PURGE AIR. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 58783493 AND THIS DEVICE PASSED ALL SPECIFICATIONS AND INSPECTIONS WITH NO NON CONFORMANCES.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: CUSTOMER REPORT OF "VENT CAP FAILED TO PURGE AIR" WAS CONFIRMED. REC'D (1) RED CANNULA VENT CAP. BLOOD WAS EVIDENT AT ENTIRE INNER SURFACE OF WHITE VENT SECTION OF THE CAP. THE CAP DID NOT ALLOW AIR TO PASS BECAUSE ENTIRE WHITE VENT SECTION OF THE CAP WAS CLOTTED UP WITH BLOOD. THE CAP WAS NOT SUPPOSED TO MAKE CONTACT WITH BLOOD UNTIL ALL THE AIR REMOVED/VENTED OUT OF THE CANNULA. THE VENT CAP WAS RECEIVED AT EDWARDS (B)(4) ON (B)(4) 2010 AND EVALUATED BY ENGINEERING. DRY BLOOD IS VISIBLE ON THE INSIDE OF THE VENT CAP WHICH WOULD PREVENT THE VENTING OF AIR. A DHR REVIEW WAS PERFORMED AND NO NON CONFORMANCES WERE FOUND FOR (B)(4). ON FURTHER INVESTIGATION OF THE BOM IT WAS FOUND THAT THERE WAS NO REQUIREMENT TO PLACE THE IFU IN THE BILL OF MATERIAL FOR (B)(4). AN ENGINEERING CHANGE REQUEST WAS INITIATED ON (B)(4) 2010 TO ADD IFU 60219 IN THE BOM FOR (B)(4). A PRODUCT RISK ASSESSMENT WAS OPENED ON (B)(4) 2010 FOR THIS EVENT AND WILL BE TRACKED TO CLOSURE. WE WILL CONTINUE TO MONITOR TRENDS BASED ON PROCEDURE ON AN ONGOING BASIS.

    Description of Event or Problem · 1

    REPORTEDLY: VENT CAP IS ATTACHED TO ARTERIAL CANNULA. DURING ARTERIAL CANNULATION OF AORTA, THE VENT CAP FAILED TO PURGE AIR IN CANNULA. THERE WAS NO SERIOUS INJURY OR ADVERSE EVENT. THE VENT CAP IS ATTACHED TO A CONNECTOR THEN TO THE ARTERIAL CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA VENT CAP VENT CAP DWF EDWARDS LIFESCIENCES SPC2063 58783493

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR