BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRD FLEX ADVANTAGE, 1.5 LTR

    MDR report key: 1871060 · Received October 15, 2010

    Report

    Report Number
    1423537-2010-00047
    Event Type
    Death
    Date Received
    October 15, 2010
    Date of Event
    June 9, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DHR OF BOTH REPRESENTATIVE SAMPLES RECEIVED FROM THE END USER WERE REVIEWED AND THERE WERE NO ISSUES DURING THE PRODUCTION OF THESE BATCH RECORDS RELATED TO SUCTION FAILURE. THE SAMPLES RECEIVED WERE REPRESENTATIVE SAMPLES FROM THE END USER AND THESE SAMPLES WERE SUBJECTED TO A SUCTION TEST AND BOTH LINERS FUNCTIONED PROPERLY. THE LINERS WERE ALSO SUBJECTED TO THE VACUUM DECAY AND ALL MET THE CRITERIA OF THIS TEST. AS TO THE CONCERN ABOUT THE DIFFERENT APPEARANCE OF THE BAG AND LID, WE PURCHASE THE BAG MATERIAL AND THE LID COLOUR MATERIAL FROM DIFFERENT SUPPLIERS WHICH MAY HAVE A SLIGHT DIFFERENCE IN THE APPEARANCE, BUT ALL MATERIALS USED ARE FULLY VALIDATED AND ALL MEET THE FORM, FIT AND FUNCTIONALITY REQUIREMENTS OF THE FLEX PRODUCT. POTENTIAL ROOT CAUSES FOR SUCTION FAILURE: LINER NOT PROPERLY CLIPPED INTO THE HARD CANISTER LEAK IN THE USER SYSTEM. HOWEVER, GIVEN THAT ALL SAMPLES RECEIVED PERFORMED AS EXPECTED, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE ISSUE REPORTED. THE FOLLOWING ACTIONS ARE BEING PERFORMED FOR THIS PRODUCT LINE. A SAMPLE IS BEING TAKEN EVERY HOUR TO CHECK FOR ANY LID DEFECT AND FOUR LIDS ARE BEING TESTED EVERY 2 HOURS FOR PROPER SUCTION. TRENDING WILL ALSO BE PERFORMED IN ORDER TO DETECT ANY TYPE OF TREND FOR THE REPORT ISSUE.

    Description of Event or Problem · 1

    PATIENT PASSED AWAY. BAD ASPIRATION QUALITY WAS NOT FORMERLY ATTRIBUTABLE TO THE PATIENT'S DEATH. NURSES AND ANAESTHETISTS EXPRESSED LACK OF SUCTION GUARANTEE DURING USE AND EMERGENCIES SITUATIONS. IT WAS SUPPOSED BEING ONE OF THE 2 VALVES DEFECT AFTER HAVING CHECKED THAT HOSPITAL VACUUM, MANOMETER AND PRODUCT ASSEMBLY WERE FUNCTIONAL. LATER A TEST COULD REPRODUCE THE INCIDENT. ASPIRATION WAS NORMAL AT PATIENT TUBING AND SUDDENLY STOPPED. DEPRESSION FROM VACUUM TUBING LEVEL UP TO LID PORT WAS FUNCTIONAL BUT AT PATIENT'S PORT, NO DEPRESSION OCCURRED JUST AS IF THE 2 VALVES WERE BLOCKED. LINER WAS CHANGED AND ASPIRATION OCCURRED. THE DEFECTIVE LINER WAS RE-CONTROLLED AND ASPIRATION WAS FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRD FLEX ADVANTAGE, 1.5 LTR APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CARDINAL HEALTH 65651920 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death