BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULAE ACCESSORIES- VENT CAP

    MDR report key: 1844373 · Received September 24, 2010

    Report

    Report Number
    1713910-2010-00267
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 25, 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

    (B)(4): VENT CAP FAILED TO PURGE AIR.PRODUCT WAS DISCARDED BY CUSTOMERA DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR LOT 58783493 ON (B)(6), 2010. NO NONCONFORMANCES WERE GENERATED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    SINCE THE VENT CAP WAS NOT RETURNED IT COULD NOT BE EVALUATED BY ENGINEERING IN UTAH. A DHR REVIEW WAS PERFORMED AND NO NON CONFORMANCES WERE FOUND FOR 58783493. ON FURTHER INVESTIGATION OF THE BILL OF MATERIAL, IT WAS FOUND THAT THERE WAS NO REQUIREMENT TO PLACE THE INSTRUCTIONS FOR USE IN THE BOM FOR SPC2063. AN ENGINEERING CHANGE REQUEST WAS INITIATED ON 11/01/2010 TO ADD IFU 60219 IN THE BOM FOR SPC2063. SINCE THE IFU WAS NOT INCLUDED WITH THE PRODUCT, IT IS POSSIBLE THAT THE USER ALLOWED BLOOD TO MAKE CONTACT WITH THE VENT PLUG PRIOR TO AIR BEING VENTED. THE CORRECTIVE ACTION IS BEING IMPLEMENTED VIA THE ECR; A CAPA IS NOT REQUIRED AT THIS TIME SINCE THIS IS AN ISOLATED INCIDENCE. A PRODUCT RISK ASSESSMENT WAS INITIATED TO ADDRESS THE MISSING IFU IN THE BILL OF MATERIAL EACH CUSTOMER EXPERIENCE REPORT IS THOROUGHLY REVIEWED TO ENSURE APPROPRIATE RISK CONTROL MEASURES ARE IN-PLACE. TRENDS WILL CONTINUE TO BE MONITORED ON AN ONGOING BASIS PER PROCEDURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: VENT CAP (B)(4) IS ATTACHED TO ARTERIAL CANNULA - (B)(4). DURING ARTERIAL CANNULATION OF AORTA, THE VENT CAP FAILED TO PURGE AIR IN CANNULA. THERE WAS NO SERIOUS INJURY OR ADVERSE EVENT: MERELY A MALFUNCTION. THE VENT CAP IS ATTACHED TO A CONNECTOR THEN TO THE ARTERIAL CANNULA: (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1