BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 1000359 · Received February 15, 2008

    Report

    Report Number
    MW5005576
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    CARDINAL HEALTH 303 INCORPORATED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT HOSPITAL, WE HAVE BRIEFLY IDENTIFIED A POTENTIAL ISSUE WITH A CARDINAL HEALTH PRODUCT ITEM NUMBER 2519A. WE HAVE BRIEFLY DONE PRELIMINARY TO CONFIRM OUR CONCERN THERE IS SIGNIFICANT POTENTIAL FOR AIR ENTRAINMENT AND SUBSEQUENT INADVERTENT VENOUS AIR EMBOLISM USING THIS DEVICE. WE FEEL THE NEED TO EXPRESS OUR GENUINE CONCERNS REGARDING THE 3 PORT MANIFOLD 2915A. CERTAINLY OUR PRELIMINARY TESTING IS NO SUBSTITUTE FOR DEFINITIVE TESTING AND I WOULD RECOMMEND MORE DEFINITIVE BENCH TESTING. OUR PRELIMINARY FINDINGS, WERE NOT FAVORABLE FOR THE CARDINAL ALARIS PRODUCT. SPECIFICALLY, ITEM 2915A FAILED OUR NEGATIVE PRESSURE AIR ENTRAINMENT TEST MISERABLY. IN ESSENCE WE WERE EASILY ABLE TO ENTRAIN AN INDEFINITE QUANTITY OF AIR INTO THE IV SET FROM AN UNCAPPED PORT WITH MINIMAL RESISTANCE. I CONTACTED OUR CARDINAL ALARIS REPRESENTATIVE AND THEIR CUSTOMER SUPPORT HOTLINE TO IDENTIFY THE POTENTIAL PROBLEM TO BEGIN A FORMAL INVESTIGATION OF OUR CONCERN SO THAT ANY NECESSARY FOLLOW UP OR ACTION CAN BE TAKEN. UNFORTUNATELY, I WAS FORCED TO LEAVE A VOICE MAIL STATING MY CONCERNS WITH THE CARDINAL ALARIS HOTLINE BECAUSE NO SUPPORT PERSON WAS AVAILABLE. SINCE THEN I HAVE BEEN CONTACTED BY THE CARDINAL ALARIS REPRESENTATIVE TO IDENTIFY MY SPECIFIC CONCERNS FOR ADDITIONAL TESTING. PLEASE CONSIDER THIS A REQUEST TO FORMALLY IDENTIFY A DESIGN FLAW WHICH SEEMS TO HAVE A SIGNIFICANT POTENTIAL FOR INADVERTENT VENOUS AIR EMBOLI AND SUBSEQUENT CATASTROPHIC OUTCOMES TO PATIENTS. I WOULD SUGGEST THE FDA RESEARCH THE CARDINAL ALARIS PRODUCT LINE, SPECIFICALLY ITEM 2915A FOR SAFETY ISSUES. I WOULD SUGGEST THE POTENTIAL FOR AIR ENTRAINMENT AND SUBSEQUENT VENOUS AIR EMBOLI USING THIS DEVICE IS SIGNIFICANT WITH THE PRESENT DESIGN FLAW. THIS RISK IS PRECIPITATED IN AN SPONTANEOUSLY BREATHING HYPOVOLEMIC PATIENT AND COULD BE FURTHER POTENTIATED BY MANIFOLD LOCATION ABOVE THE HEART AS NECESSITATED IN MANY SURGICAL PROCEDURES. WE WERE EASILY ABLE TO ENTRAIN A SEEMINGLY ENDLESS VOLUME OF AIR WITH VERY LITTLE RESISTANCE. THE RAMIFICATIONS OF SUCH AN EVENT COULD BE POTENTIALLY CATASTROPHIC FOR ANY PATIENT. WE HAVE CHOSEN ANOTHER VENDOR TO PROVIDE WHAT WE DEEM AN ACCEPTABLE SUBSTITUTE FOR ITEM 2519A. WE HAVE DECIDED TO REMOVE THIS ITEM FROM OUR INVENTORY. I AM HAPPY TO SPEAK WITH YOU ABOUT MY SPECIFIC CONCERNS AND TESTING OF THE CARDINAL ALARIS 2915A MANIFOLD. WE FEEL THAT OUR CONCERNS WARRANT FURTHER INVESTIGATION BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH 3 PORT MANIFOLD 5 INCH 3 1 WAY PORT FPA CARDINAL HEALTH 303 INCORPORATED 2519A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR