BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART CAPNOLINE H PEDIATRIC

    MDR report key: 2509539 · Received March 22, 2012

    Report

    Report Number
    8044004-2012-00001
    Event Type
    Other
    Date Received
    March 22, 2012
    Date of Event
    January 30, 2012
    Report Date
    March 21, 2012
    Manufacturer
    ORIDION MEDICAL 1987 LTD.
    Product Code
    CCK
    PMA / PMN Number
    K011050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLING LINE REGARDING WHICH THIS REPORT IS BEING FILED INCLUDES A DEHUMIDIFYING MATERIAL (NAFION). ON MARCH 2012, FOLLOWING THE ABOVE REPORT, THE COMPANY RETESTED THE NAFION TUBE ((B)(4)), AND IT WAS FOUND THAT IN SOME CASES IT CAN PRODUCE A DISTORTION TO AN MRI IMAGE. THE DISTORTION MAY CREATE A SHADOW IN THE MRI SCAN AND HENCE COULD POTENTIALLY MISLEAD THE PHYSICIAN. THE COMPANY BELIEVES THAT THE PROBABILITY OF THIS SCENARIO IS VERY LOW SINCE IN THIS CASE THE ARTIFACT WAS CLEARLY VISIBLE TO THE CLINICAL TEAM AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED, DESPITE THE FACT THAT (B)(4) ORIDION SAMPLING LINES WITH NAFION HAVE ALREADY BEEN PLACED ON THE MARKET. NO DIRECT HARM TO PT IS EXPECTED, SINCE THE STAINLESS STEEL INSIDE THE NAFION TUBE IS COVERED BY PLASTIC AND HENCE DOES NOT COME IN CONTACT WITH THE PT SKIN. THE COMPANY HAS DECIDED TO REVISE THE USER MANUAL (BOTH CAPNOGRAPHS AND SAMPLING LINES) TO CAUTION THE USER NOT TO USE THE SAMPLING LINES WHICH INCLUDE NATION (H FAMILY OF PRODUCTS) DURING MRI SCANNING. THE FOLLOWING CAUTION WILL BE ADDED: CAUTION: USE OF A CO2 SAMPLING LINE WITH H IN ITS NAME (INDICATING THAT IT IS FOR USE IN HUMIDIFIED ENVIRONMENTS) DURING MRI SCANNING MAY CAUSE INTERFERENCE. THE USE OF NON H SAMPLING LINES IS ADVISED. THE COMPANY WILL CONTINUE TO VIGILANTLY MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    ON (B)(4) 2012, ORIDION RECEIVED INFO FROM THE COMPANY DISTRIBUTOR RELATED TO THE USE OF SMART CAPNOLINE H (ORIDION PH 010581) IN AN MRI ENVIRONMENT: (B)(6) HOSPITAL, MRI ENVIRONMENT: MRI DEPT ENCOUNTERED A DISTURBANCE ALLEGEDLY CAUSED BY THE FILTERLINE DURING AN MRI SCAN. THE DISTURBANCE WAS DEMONSTRATED BY A SHADOW ON THE MRI SCAN. THE ARTIFACT WAS RECOGNIZED BY THE RADIOLOGIST AND DIDN'T LEAD TO A MISDIAGNOSIS. IT WAS ALSO REPORTED THAT THE FILTERLINE LEFT A MARK ON THE PT'S SKIN. THE COMPANY CONTACTED THE CLINICAL TEAM SEVERAL TIMES TO RECEIVE MORE INFO AND ON MARCH 12 RECEIVED INFO INDICATING THAT THE MARK WAS PROBABLY RELATED TO THE POSITIONING OF THE PT AND THAT THEY DID NOT BELIEVE IT WAS AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CAPNOLINE H PEDIATRIC CCK ORIDION MEDICAL 1987 LTD. 010581 M6798A9

    Patients

    Seq Age Sex Outcome Treatment
    1