BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFIRM NOW CO2 DETECTOR

    MDR report key: 3131002 · Received May 21, 2013

    Report

    Report Number
    1282497-2013-00018
    Event Type
    Death
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH THE EASYCAP AND A CONFIRM NOW. THE CUSTOMER STATED DURING A CODE THE CUSTOMER COULD NOT DIFFERENTIATE BETWEEN THE EASYCAP II AND THE COVIDIEN KANGAROO CO2 DETECTOR FOR GASTRIC TUBE PLACEMENT. AS A RESULT OF THE TWO PACKAGES LOOKING SIMILAR, THE FACILITY HAD AN INTERNAL SYS ERROR WHERE KANGAROO CO2 DETECTOR AND THE EASY CAP II WERE INCORRECTLY PLACED IN THE HOSPITAL. A CODE WAS CALLED ON A PT FLOOR THAT DOES NOT EXPERIENCE CODES OFTEN. THE PT WAS INTUBATED BY THE CODE TEAM AND THEY OPENED WHAT THEY THOUGHT WAS AN EASYCAP, BUT REALIZED THAT THEY HAD GRABBED A CONFIRM NOW. THE CONFIRM NOW DEVICE WAS NEVER USED AND WAS DISCARDED IMMEDIATELY. WHILE A CODE TEAM MEMBER RAN TO FIND AN EASYCAP A CLINICAL DECISION WAS MADE TO EXTUBATE AND RE-INTUBATE THE PT. THE CUSTOMER WAS UNSURE OF THE REASON FOR EXTUBATION. THE CODE RAN FOR APPROXIMATELY 30-40 MINUTES AND THE CLINICIANS WERE ABLE TO GET THE PT STABLE ENOUGH TO TRANSFER THE PT TO THE OPERATING ROOM. WHILE THE PT WAS IN THE OPERATING ROOM THE PT EXPIRED. THE CUSTOMER STATED THAT THE PT'S DEATH HAD NOTHING TO DO WITH THE DELAY IN TIME FOR EXTUBATION AND RE-INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225181 CONFIRM NOW CO2 DETECTOR CO2 DETECTOR KNT COVIDIEN 777702 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death