FDA Adverse Event Death Summary report: N

EASY CAP II CO2 DETECTOR

MDR report key: 2065716 · Received April 15, 2011

Report

Report Number
MW5020304
Event Type
Death
Date Received
April 15, 2011
Date of Event
March 7, 2011
Report Date
April 15, 2011
Manufacturer
NELLCOR HEALTHCARE GROUP LP
Product Code
CCK
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

ON THE EVENING OF (B)(6) 2011, OUR ANESTHESIA SERVICE RESPONDED TO A REQUEST FOR EMERGENCY ENDOTRACHEAL INTUBATION OF A PT SUFFERING VENTILATORY FAILURE FOLLOWING CARDIAC SURGERY. THE PT HAD BEEN EXTUBATED SEVERAL HRS PREVIOUS TO OUR BEING CALLED AND WAS FOUND TO BE DYSPNEIC ON A CPAP MASK. AFTER ADMINISTRATION OF ETOMIDATE AND SUCCINYLCHOLINE, AN ENDOTRACHEAL TUBE WAS PLACED AND CONNECTED TO AN AMBU-TYPE SELF-INFLATING BAG. POSITION OF THE TUBE WAS CONFIRMED IN PART BY COLOR CHANGE NOTED FOR 6 BREATHS ON A EASY CAP II CO2 DETECTOR -NELLCOR HEALTHCARE (B)(4). THE EASY CAP WAS REMOVED AND THE PT PLACED ON A VENTILATOR. SHORTLY THEREAFTER, SHE SUFFERED A CARDIAC ARREST. DURING RESUSCITATION, A SENIOR ANESTHESIOLOGIST RESPONDED AND NOTED, THE PT'S ABDOMEN TO BE DISTENDED. THE ENDOTRACHEAL TUBE WAS CHECKED AND FOUND TO BE IN THE ESOPHAGUS. IT WAS THEN MOVED TO THE TRACHEA AND THE PT WAS RESUSCITATED, BUT SUFFERED ANOXIC BRAIN DAMAGE AND SUBSEQUENTLY EXPIRED. WE BELIEVE THAT THE ENDOTRACHEAL TUBE WAS INITIALLY MISPLACED AND THE COLOR CHANGE OF THE EASY CAP (LIKELY FROM CO2 IN THE STOMACH) FALSELY INDICATED, THE TUBE WAS CORRECTLY POSITIONED. WE FEEL THERE SHOULD BE A WARNING ON THIS DEVICE THAT FALSE POSITIVE READINGS MAY BE ENCOUNTERED, ESPECIALLY IN CASES WHERE PTS MAY BE ON CPAP-ASSISTED MASK OR NASAL VENTILATION. HAD THE EASY CAP NOT LED THE TEAM TO BELIEVE THE TUBE WAS IN THE TRACHEA, THEY MAY HAVE LOOKED MORE CLOSELY AT OTHER CLINICAL SIGNS AND INTERVENED EARLIER, WHICH MAY HAVE PREVENTED THIS PT'S INJURY AND DEATH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EASY CAP II CO2 DETECTOR NONE CCK NELLCOR HEALTHCARE GROUP LP

Patients

Seq Age Sex Outcome Treatment
1 75 YR Death| R