BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR EASY CAP II

    MDR report key: 2140900 · Received June 17, 2011

    Report

    Report Number
    2936999-2011-00419
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    March 7, 2011
    Report Date
    May 19, 2011
    Manufacturer
    COVIDIEN/ FORMERLY TYCO
    Product Code
    CCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EASYCAP DIRECTIONS FOR USE WHICH ARE DIRECTLY RELEVANT TO THE EVENTS REPORTED BY THE FACILITY ARE AS FOLLOWS: "WARNING: INTERPRETING RESULTS BEFORE CONFIRMING SIX BREATH CYCLES CAN YIELD FALSE RESULTS." "GASTRIC DISTENTION WITH AIR PRIOR TO ATTEMPTED INTUBATION MAY INTRODUCE CO2 LEVELS AS HIGH AS 4.5% INTO THE EASYCAP II DETECTOR IF THE ENDOTRACHEAL TUBE IS MISPLACED IN THE ESOPHAGUS. INITIAL EASYCAP II DETECTOR COLOR (YELLOW) MAY BE INTERPRETED AS A FALSE POSITIVE IF READ BEFORE DELIVERY OF SIX BREATHS." "STANDARD CLINICAL ASSESSMENT SHOULD BE USED TO CONFIRM PROPER POSITION OF THE ENDOTRACHEAL TUBE WITHIN THE TRACHEA." THE DECISION TREE IN THE INTERPRETATION SECTION OF THE EASYCAP DIRECTIONS FOR USE PROVIDES AS FOLLOWS AFTER DELIVERY OF 6 BREATHS: IF THE INDICATOR COLOR IS IN COLOR RANGE B (TAN), THEN EITHER THERE IS "RETAINED CO2 IN ESOPHAGUS" OR "LOW PULMONARY BLOOD FLOW, HYPOCARBIA." THE DECISION TREE THEN DIRECTS TO DELIVER 6 MORE BREATHS AND TAKE ADD'L INTERPRETIVE STEPS. IF THE INDICATOR COLOR IS IN COLOR RANGE C (YELLOW), THE DECISION TREE STATES "ET TUBE IN TRACHEA, CONTINUE TO OBSERVE COLOR CHANGE." OTHER RELEVANT INSTRUCTIONS IN THE DIRECTIONS FOR USE ARE: "REMOVE AND DISCARD THE DEVICE AFTER USE, NOT TO EXCEED 2 HRS." "NOTE THAT THE INDICATOR COLOR WILL CONTINUE TO FLUCTUATE FROM INSPIRATION TO EXPIRATION FOR UP TO 2 HRS." AS PREVIOUSLY NOTED, THE RESIDENT USING THE EASYCAP WAS NOT CERTAIN IF THE COLOR WAS TAN OR YELLOW AFTER 6 BREATHS, AND THE EASYCAP WAS IMMEDIATELY REMOVED FOLLOWING THE INITIAL 6 BREATHS.

    Description of Event or Problem · 1

    ON (B)(4), 2011, COVIDIEN REC'D MAUDE REPORT NO. (B)(4) WHICH REPORTED THE FOLLOWING CONCERNING AN INCIDENT ON (B)(6) 2011: A CLINICIAN HAD INTUBATED A PT WHO HAD BEEN FOUND TO BE DYSPNEIC ON A CPAP MASK. THE CLINICIAN CONFIRMED THE POSITION OF THE ET TUBE IN PART BY NOTING COLOR CHANGE FOR 6 BREATHS ON AN EASYCAP II CO2 DETECTOR. THE EASYCAP WAS REMOVED AND THE PT PLACED ON A VENTILATOR. SHORTLY THEREAFTER, THE PT SUFFERED A CARDIAC ARREST, AND A RESPONDING SENIOR ANESTHESIOLOGIST NOTED THAT THE PT'S ABDOMEN WAS DISTENDED. THE ET TUBE WAS THEN FOUND TO BE IN THE ESOPHAGUS. THE PT ULTIMATELY EXPIRED. THE MAUDE REPORT FURTHER STATES THAT THE COLOR CHANGE ON THE EASYCAP WAS LIKELY FROM CO2 IN THE STOMACH AND THAT THERE SHOULD BE A WARNING ABOUT THE POSSIBILITY OF FALSE POSITIVE READINGS. IN A F/U CONVERSATION, THE FACILITY INFORMED COVIDIEN THAT THERE WAS NOT AN ISSUE WITH THE EASYCAP. COVIDIEN OBTAINED THE FOLLOWING ADD'L INFO IN THE F/U CONVERSATION WITH THE FACILITY: THE ANESTHESIA RESIDENT WHO RESPONDED TO THE REQUEST FOR EMERGENCY INTUBATION HAD REPORTED THAT THE EASYCAP WAS REMOVED AT THE END OF THE SIXTH BREATH. THE RESIDENT HAD OBSERVED THAT THE EASYCAP HAD CHANGED COLOR FROM PURPLE TO EITHER TAN OR YELLOW. THE EASYCAP DIRECTIONS FOR USE CONTAIN A NUMBER OF WARNINGS AND INSTRUCTIONS THAT ARE DIRECTLY RELEVANT TO THE EVENTS REPORTED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR EASY CAP II CO2 DETECTOR CCK COVIDIEN/ FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death