BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND-L SENSOR

    MDR report key: 614775 · Received July 23, 2004

    Report

    Report Number
    9612233-2004-00015
    Event Type
    Other
    Date Received
    July 23, 2004
    Date of Event
    June 26, 2004
    Report Date
    June 28, 2004
    Manufacturer
    DIAMETRICS MEDICAL, LTD.
    Product Code
    CCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON SUCCESSFUL CALIBRATION, A NEOTREND-L SENSOR WAS ATTACHED TO THE VAC AND SENSOR INSERTION WAS ATTEMPTED. THE SENSOR WOULD NOT PENETRATE PAST THE VAC HUB. AFTER MANY ATTEMPTS, BLOOD WAS SEEN BACKING UP THE VAC AND THEN INTO THE SENSOR AND OUT OF THE ADVANCEMENT LOCK.AFTER CLOSE EXAMINATION OF THE VAC, IT WAS NOTED THAT THE VAC WAS AN ARGYLE 3.5 FR AND NOT A DML 3.7 FR. NO INTERVENTION WAS REQUIRED DUE TO THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO