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Based on record review and interview the facility failed to minimize the concentration of oxygen at the surgical site to prevent possible fire when using electrosurgical equipment in 1 of 1 patients (Patient #1) where a burn injury occurred out of a total 10 records reviewed.

Findings include:

The facility failed to ensure policies were designed and implemented to minimize the concentration of oxygen at the surgical site to prevent possible fire when using electrosurgical equipment. See Tag A-0951

Based on record review and interview the facility failed to minimize the concentration of oxygen at the surgical site to prevent possible fire when using electrosurgical equipment during surgery and failed to communicate about an open oxygen source during surgery for 1 of 1 patients (Patient #1) where a surgical fire and burn injury occurred out of a total 10 records reviewed.

Findings:

A review of the facility policy, titled "[facility name] Operating Room (OR) Fire Safety Plan", last reviewed 8/30/2021, revealed: "Policy: ...2. Prior to every surgical procedure, the fire risks associated with the procedure will be addressed by the surgical staff during the Time Out. Fire risks that should be addressed include ignition sources that are present, fuels that are present and the potential for the presence of an oxygen-enriched environment in the Operating Room. Procedure: 1. Potential Hazards: a. The three elements required to initiate a fire include: - Ignition Source (ex: (example) Electrocautery, lasers, fiber optic light sources, drills, etc.) - Fuel (ex: prep, drapes, gauze, tubes, body hair, mattresses, etc.) - Oxidizer (ex: oxygen and nitrous oxide) 2. Fire Prevention: ...c. Oxidizer-use oxidizers with caution near any ignition or fuel sources. The anesthesia professional should verify that the anesthesia circuit is free of any leaks. Avoid use of blow-by oxygen. In the event an open gas delivery systems needs to be used during a surgical procedure, the Surgeon and Anesthesiologist will remain in direct communication with each other in order to reduce the risk of fire while maintaining adequate patient care...."

A review of the Operative Note filed on 2/13/2023 at 7:27 AM by Cardio-thoracic (CT) surgeon J, revealed: "Date of Procedure: 2/10/2023; Procedure: Bilateral lung transplantation on ECMO support; Description of Procedure: ...Basically, I had completely divided the bronchus and was just completing the division of the bronchus in the very low edge when we had a significant complication, and these are the following events that occurred at that time. When I was finishing dividing the bronchus, I noticed a catheter that was there inadvertently placed on the right side. This was a high flow oxygen catheter that was just inadvertently placed on the right side through an open bronchus, I was using the electrocautery as we do routinely and as I have done on hundreds of transplantations and because of the current (electrical) the catheter which was delivering high oxygen in the area inadvertently immediately got on fire. The lung had no flow for at least 10 to 15 minutes since the pulmonary artery was divided, so there was absolutely no reason to have a catheter there delivering oxygen .... When the catheter started on fire, something that the 3 of us saw together, myself and the 2 assistants, the fire clearly started on the tip of this catheter as a flame and in seconds migrated proximally. At that time, we immediately said that there was a fire in the catheter, and we asked immediately for water, normal saline bucket (sic) and we told the entire team in the room that there was a fire..."

A review of the Anesthesia Summary completed on 2/11/2023 8:08 AM, revealed: "11:24 PM Quick note: Anesthesia emergency: Airway fire event. Initially, had sudden near complete loss of end-tidal CO2 (this noninvasive technique provides a breath-by-breath analysis and a continuous recording of ventilatory status) and tidal volume (the amount of air you move through your lungs each time you inhale and exhale while you're at rest) while on one lung ventilation of the left lung with the right lung still collapsed. After informing the surgical team of loss of ventilation, we manually ventilated the patient with the bag on the ventilator to assess the leak and simultaneously prepared the bronchoscope to assess the position of the double lumen tube... Hypothesis for airway fire: The sudden loss of end-tidal CO2 and tidal volume was indicative of a leak. As we were not manipulating the ventilator or circuit in any way, the sudden nature of it suggested dislodgement of a previously well-positioned DLT (double lumen tube-used for ventilation) (i.e., the patient had adequate ventilation with appropriate lung isolation prior to this sudden event, and the position of the DLT was confirmed with fiberoptic bronchoscope at the beginning of the case). As such, the tube most likely migrated superiorly, with the bronchial cuff now sitting in the main trachea, effectively losing ventilatory isolation of the left lung. As we were ventilating the left lung with 100% FiO2 secondary to hypoxemia (low oxygen level) during one lung ventilation, this leak would cause high FiO2 of oxygen to exit from the left lung into the right bronchus which was now open. Electrocautery in the right chest would then spark the high FiO2 after further delivery of manual breaths, initiating the fire. There had been a suction catheter that was previously placed down the tracheal/right side of the DLT to passively oxygenate the collapsed right lung with 4L/min of O2 secondary to hypoxemia (this is a strategy for refractory hypoxemia during one lung ventilation, especially in this case as the patient desaturates into the 70's and 80s with collapse of the right lung secondary to 63% of his pulmonary perfusion entering the right lung). Once the fire was initiated from sparking of the high FiO2 from the leak, the flame propagated up the path of least resistance, which was the catheter that was delivering 4L/min of O2, and subsequently further up into the patient's double lumen tube."

During an interview on 2/15/2023 at 9:45 AM, Vice President of Quality A stated, "I was called at 1:00 AM on 2/11/2023 regarding the OR airway fire. We held an Event Understanding Meeting today at 6:00 AM which included the entire surgical and anesthesia team involved in the incident and the Patient Safety/Risk Management team. This is an active investigation."

During an interview on 2/15/2023 at 11:10 AM, Cardio-thoracic (CT) surgeon J stated, "There was a suction catheter delivering oxygen in the right bronchus, which I was not aware of, if the catheter had not been there the fire would never of taken place. Truth is that the suction catheter in the right bronchus shouldn't have been there, it wasn't doing anything because the flow to the right lung was blocked."

During an interview on 2/15/2023 at 11:20 AM, CT surgeon (fellow) K stated, "Surgery was progressing well, we didn't know about the suction catheter delivering oxygen was in the right bronchus. The anesthesiologist did not inform anyone of the catheter, which is not typically used during lung transplant surgery..." When asked if he heard Anesthesiologist N say that he was having a hard time ventilating the patient, CT surgeon K stated, "I don't remember hearing that." When asked if it was typical to pause prior to using cautery, Surgeon K stated, "No."

During an interview on 2/15/2023 at 12:20 PM, Anesthesiologist N stated, "The patient had a double lumen endotracheal tube in for ventilation. When the right lung was collapsed the patient oxygen saturation went down into the 70's, so I placed a suction catheter delivering 4L of oxygen down the right lumen of the tube to provide passive oxygen. Then I lost end tidal volumes (unable to ventilate the patient) so I switched to manual breaths by bagging the patient with 100% FiO2 and tried to assess if there was an airway leak, I told the surgical team I lost end tidal volumes... Once everyone was informed of the loss of tidal volume-people (surgical and anesthesia teams) should have paused and if anyone smells anesthesia gas, we should pause and check for a leak."

During an interview on 2/16/2023 at 10:15 AM, Executive Director of Patient Safety C stated, "We have put in place an Immediate mitigation intervention and it has been addressed with the anesthesia department, CT surgery division and lung transplant CT surgeons, Advanced Practice Providers, Surgical Assistants, Perfusionists, department leaders and the OR CT surgical team."

Review of the facility document titled, "Urgent Attention Required", not dated, revealed: "Situation: A recent serious safety event resulted in airway fire during bilateral lung transplant, and requires safety evaluation to prevent future patient harm. We must implement immediate mitigation strategies by 2/16/2023 as we work to enhance the process further upstream. Immediate Mitgation Intervention: 1. For lung transplants, implement a 'frozen moment' where the entire teams pauses: a. Prior to the first time electrocautery is brought to the field. At this point anesthesiologist and surgeon confirm that there is a minimized risk of fire with electrocautery use at this point. b. If a significant concern with ventilation occurs, electrocautery use will be paused and a second 'frozen moment' will occur to ensure that there is a minimized risk of fire a this point."