BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND-L SENSOR

    MDR report key: 904467 · Received October 8, 2004

    Report

    Report Number
    9612233-2004-00023
    Event Type
    Other
    Date Received
    October 8, 2004
    Date of Event
    September 16, 2004
    Report Date
    September 16, 2004
    Manufacturer
    DIAMETRICS MEDICAL, LTD.
    Product Code
    CCE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DIFFICULTIES WERE EXPERIENCED DURING THE ATTEMPTED INSERTION OF A NEOTREND-L SENSOR INTO A 3.7 FR DMI UMBILICAL ARTERY CATHETER (UAC). DURING THE INITIAL SENSOR ADVANCEMENT MANEUVER, THE SENSOR WOULD NOT EXTEND OUT OF THE Y-PIECE. BY THE SECOND ATTEMPT, BLOOD BEGAN BACKING UP THE UAC AND INTO THE SENSOR. THE NEOTREND-L SENSOR WAS REMOVED FROM THE UAC AND DISCARDED BY THE CUSTOMER. THIS PREVENTED A FULL INVESTIGATION FROM BEING PERFORMED. INVESTIGATIONS INTO SIMILAR INCIDENTS REPORTED RECENTLY HAVE DETERMINED THAT RESISTANCE ENCOUNTERED DURING SENSOR INSERTION MAY BE CAUSED BY THE NEOTREND-L Y-PIECE SEAL NOT PERMITTING THE SMOOTH PASSAGE OF THE SENSOR. INVESTIGATIONS INDICATE THAT THE BUTT WELD, THE JOIN BETWEEN THE NARROW DIAMETER OF THE SENSING REGION OF THE SENSOR AND THE SOLID WALL, MAY BE SUBJECT TO FRICTIONAL FORCES, WHICH MAKES THE SENSOR MORE DIFFICULT TO INSERT. REPEATED AND INAPPROPRIATE ATTEMPTS BY THE USER TO INSERT AND WITHDRAW THE SENSOR MAY RESULT IN THE BUCKLING OF THE SENSOR TOWARDS THE PROXIMAL END, EFFECTIVELY SHORTENING THE SENSOR LENGTH. ONCE SHORTENED, THE BUTT WELD CAN PASS INTO OR THROUGH THE Y-PIECE SEAL PROVIDING A FLUID PATH BEYOND THE Y-PIECE. DML IS IN THE PROCESS OF MAKING DESIGN MODIFICATIONS TO THE SENSOR Y-PIECE AND TO PROTECT AGAINST INAPPROPRIATE USE, WHICH MAY LEAD TO BLOOD LEAKAGE. WITHOUT THE RETURN OF THE NEOTREND-L SENSOR, DML IS UNABLE TO DETERMINE CONCLUSIVELY THE CAUSE OF THE REPORTED BLOOD LEAKAGE INTO THE SENSOR DETAILED IN THIS INCIDENT.

    Description of Event or Problem · 1

    NEOTREND-L SENSOR CALIBRATED WITHOUT ISSUE AND AN ATTEMPT TO INSERT INTO A DMI 3.7 FR UAC. DURING THE INITIAL SENSOR ADVANCEMENT MANEUVER, THE SENSOR WOULD NOT EXTEND OUT OF THE Y-PORT. BY THE SECOND ATTEMPT, BLOOD BEGAN BACKING UP THE UAC AND THEN INTO THE SENSOR. THE SENSOR WAS REMOVED FROM THE UAC AND DISCARDED. NO REPORT OF HARM OR INJURY TO THE PT HAS BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTREND-L SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL, LTD. N7004L 919

    Patients

    Seq Age Sex Outcome Treatment
    1 YR