Ongoing Risk: Misconnections of Tracheostomy Pilot Balloon Ports with IV Infusions Can Result in Fatal Outcomes
Problem: Inadvertent tubing misconnections pose a significant risk to patients. They often occur when luer-compatible tubing is mistakenly connected to another type of tubing into which it can fit but for which it was not designed. To help prevent dangerous misconnections, the International Organization for Standardization (ISO) developed manufacturing standards (80369) for small bore connectors to make it nearly impossible to connect tubing delivery systems that serve different routes of administration and/or functions.1 The standards are being introduced in phases, which began with enteral feeding connectors (ENFit) and are continuing presently with neuraxial connectors (NRFit). Unique challenges have led to slow implementation of the new enteral and neuraxial connectors, and until old supplies are depleted, temporary adaptors have been introduced for ENFit to connect the old tubing with the new tubing. Engineering changes for connectors associated with limb cuff inflation applications and breathing systems and driving gases applications have not yet begun. Thus, many catheters, medical tubes, and devices with different functions can still easily be connected or possibly rigged with temporary adaptors to make a leak-free connection, contributing to ongoing tubing misconnections.
Recent tracheostomy pilot balloon port misconnection
We recently learned about a misconnection between intravenous (IV) tubing and a tracheostomy pilot balloon port (cuff inflation port) that led to a young patient’s cardiac arrest. A nurse planned to administer an antibiotic to the patient via a triple lumen IV catheter. Before administering the antibiotic, the nurse removed a fully infused plain IV bag and tubing from the triple lumen IV catheter port. But instead of attaching the antibiotic to this port, the nearby tracheostomy pilot balloon port was accidentally grabbed.
The pilot balloon port is attached to tubing that inflates the cuff at the base of the tracheostomy tube to hold it in place within the trachea. The balloon inflates along with the cuff and serves as an indication of how much air pressure is in the cuff. The pilot balloon port has a luer connector, forcing practitioners to use a parenteral syringe to inflate and deflate the cuff with air.
The nurse noticed that the pilot balloon port looked different than expected and thought the triple lumen IV catheter connector had accidentally been removed from the central line when discontinuing the IV bag. Thus, a new multi-lumen extension tube was attached to what was thought to be the central IV line, and then the IV antibiotic was connected. The antibiotic, however, was attached to the tracheostomy pilot balloon port. The infusion inflated the tracheostomy cuff (Figure 1), occluded the airway, and finally burst, allowing fluid to enter the patient’s lungs. The patient arrested but was fortunately resuscitated.
It may be hard to understand how one could mistake a tracheostomy pilot balloon port for a triple lumen IV catheter port, but several underlying factors allowed this error to happen. First, the nurse had just traced and labeled the patient’s lines and did not think to conduct this safety check again. Factors impacting clear visualization of the lines included the position of the pump on the opposite side of the IV lines and the dim lights in the room. The risk of error was heightened because the patient’s triple lumen IV catheter was not secured, so the tubing hung down at the same level as the tracheostomy pilot balloon port. Although the size of the tracheostomy pilot balloon tubing is narrower than regular IV tubing, triple lumen lines are also thin. Also, because the pilot balloon port is usually not capped, it invites insertion of a compatible connector.2 The fact that the nurse thought the triple lumen IV connector had inadvertently been removed from the central line port when discontinuing the IV bag also played a role in the error.
In this hospital, due to current fluid shortages, antibiotics were typically being administered directly via the triple lumen IV catheter ports; however, prior to the shortage, antibiotics were always infused via a secondary line. The error may not have occurred if the antibiotic had been administered as a secondary infusion and attached to an access port of the infusing primary IV solution. Finally, it is also important to mention that the multi-lumen IV extension tube easily connected to the tracheostomy pilot balloon port. Again, the pilot balloon port is compatible with luer syringes (and IV connectors and tubing) for easy inflation and deflation. Unfortunately, the infusion pump provided sufficient pressure to overinflate the cuff, but it did not alarm or stop.
Replication of this event confirmed that infusion pumps will not alarm before rupture as long as the cuff can expand. Because high-volume, low-pressure cuffs are used to lower the long-term risk of tracheal injury, they are compliant enough to accept a massive volume of air—or fluid in this case. According to ECRI Institute, the pressure generated by a typical infusion (or enteral feeding) pump is sufficient to overinflate such cuffs and occlude a patient’s airway.2 Testing identified that infusion pumps will fill the cuff with approximately 70 mL of fluid3 or more before rupture.
Previously published tracheostomy pilot balloon port misconnections
While it is believed that medical tubing misconnections are vastly underreported,4 especially when patient harm does not result, misconnections between tracheostomy pilot balloon ports and IV or enteral feeding lines have been previously reported to external organizations such as ISMP, The Joint Commission (TJC), the US Food and Drug Administration (FDA), and ECRI Institute. Some of these misconnections have resulted in adult and pediatric fatalities.
As early as 1986, ECRI Institute reported an event in which an enteral pump set was inadvertently connected to a tracheostomy pilot balloon port on a cuffed endotracheal tube.2 The port on the pilot balloon tubing was similar in shape and color to the feeding tube connector. The enteral formula overinflated the endotracheal tube cuff, completely occluding the tracheal tube. The ventilator alarmed, and the patient experienced respiratory arrest but fortunately survived.
In 2001, ISMP published a similar event that resulted in a fatality.5 The patient had both a tracheostomy tube and a triple lumen IV catheter in place. A practitioner accidentally attached an IV fluid line to the tracheostomy pilot balloon port instead of the intended port on the triple lumen IV catheter. Once the IV infusion pump was turned on, the cuff continued to inflate with fluid causing the tracheostomy tube lumen to collapse and obstruct the airway. A roommate called a nurse when the patient developed respiratory distress. The patient arrested, and the obstruction was noticed when the code team was unable to inflate the lungs. The line was disconnected and the cuff was deflated, but the patient did not survive.
In 2005, an IV-tracheostomy pilot balloon port misconnection reported to FDA’s adverse event report database was published.6 A patient injured in a car accident required a tracheotomy during hospitalization after attempts to wean her off of a ventilator were unsuccessful. Shortly after the patient was transferred from the intensive care unit (ICU) to a general medical unit, a visitor reported that the patient was having difficulty breathing. Attempts to suction the patient failed, and the suction catheter could not be advanced even after the tracheostomy tube’s inner cannula was removed. Investigation revealed that, upon transfer, the patient’s IV tubing had been inadvertently connected to the tracheostomy pilot balloon port, overinflating the cuff and partially collapsing the tracheostomy tube. The patient’s outcome was not reported.
Another event reported to FDA and used as a case study for medical device misconnections involved a child in a pediatric ICU who had both an IV line and a tracheostomy tube.7 The IV tubing was mistakenly connected to the tracheostomy pilot balloon port (Figure 2). The IV fluid expanded the cuff to the point of rupture, causing continuous IV fluids to enter the child’s lungs. Tragically, the child died.
In 2006, TJC published one permanently disabling and eight fatal cases of misconnections reported to its Sentinel Event database, affecting two infants and seven adults.8 One of these cases involved the injection of IV fluid into a tracheostomy pilot balloon port.
In 2007, ISMP published yet another case.9 While bathing a patient, a nurse accidentally connected IV tubing to the patient’s tracheostomy pilot balloon port. Normally, patients wear gowns with sleeves that snap closed. But on this day, the patient wore a gown without snaps. To remove the gown, the nurse disconnected the patient’s IV insulin infusion and threaded it through the sleeve. When reconnecting the tubing, she connected the IV line to the tracheostomy pilot balloon port. Fluid began to further inflate the cuff. The error was noticed when the patient became cyanotic. The IV line was disconnected from the pilot balloon port, and 30 mL of fluid was removed from the balloon. Fortunately, the patient was not permanently harmed.
Safe Practice Recommendations: Due to the continuing risks of tubing misconnections between IV/enteral tubing and tracheostomy pilot balloon ports, consider the following:
- Conduct pre-purchase evaluations (e.g., failure mode and effects analysis) in which clinicians can manually manipulate new tubes, catheters, connectors, syringes, and tracheostomy/endotracheal tubes to uncover misconnection hazards before purchasing and using the new devices. Refusal to purchase unsafe equipment will also drive manufacturers to create better designed devices.
- In general, avoid purchasing non-intravenous devices that are equipped with connectors that can physically connect with a luer IV connector. If you must purchase devices that may allow misconnections, choose those that alarm if a misconnection has occurred, if available, or use other means of alerting staff to possible misconnections through patient monitoring (e.g., pulse oximetry, capnography, cardiac monitoring, frequent observation).
- Alert clinicians, including respiratory therapists, to the risk of misconnecting IV/enteral tubing, parenteral syringes, or flushes to a tracheostomy pilot balloon port or any other luer-compatible connector.
- Emphasize the risk of misconnections between IV/enteral tubing and tracheostomy pilot balloon ports in orientation and training curricula. Include discussions about possible sources of error identified during device pre-purchase evaluations and steps to avoid these errors. Use simulation of these misconnections to reinforce the education.
- Affix labels on lines near insertion sites when the patient has more than one potential connection to a port of entry into the body (e.g., IV, enteral, tracheostomy).
- When appropriate, position the respective delivery system (e.g., pump) on the same side of the patient from which the catheter exits. If possible, position catheters and tubes that have different purposes on different sides of the patient’s body.
- Always trace lines from their respective sources (and infusion pump if used) to the patient’s access site into the body before making connections or administering medications or solutions. Remind staff that, for patients with multiple tubes, situational awareness of each tube’s location and insertion site can be lost, especially if tubing is obscured by bedclothes and sheets, or the tubes are located on the opposite side of the bed.
- Turn on the light in a darkened room or use an articulating lamp or flashlight before connecting or reconnecting tubes or other devices.
- Limit the frequency of disconnecting and reconnecting tubing (e.g., threading the tubing through clothing) to reduce the risk of misconnections and infections.
- Develop a standardized “line reconciliation” process to recheck all connections and trace all patient tubes and catheters to their source when patients arrive in a new setting or as part of a handoff process. If not already done, label all tubes and catheters at the point(s) of connection.
- Independently double check all line attachments with two practitioners if infusing high-alert medications or solutions, or if administering products to high-risk patients, to verify correct line attachment before administration.
Assess and report misconnections
- Annually assess the potential for tubing misconnections with medical devices, connectors, and tubing used in your facility. To accomplish this, one hospital told us that they collect all the different types of tubing supplies, connectors, and devices used in the facility and ask staff (e.g., nurses, respiratory therapists, radiology technicians, transporters) to try to misconnect the different components. Afterwards, they assign severity scores to the components that could be misconnected and develop a mitigation strategy to prevent potential patient harm. An updated Tubing Misconnections Self-Assessment Tool for Healthcare Facilities, which was created by the Baxter Clinical Center of Excellence in collaboration with ISMP, is also freely available to guide organizations through a comprehensive risk assessment. (See boxed feature about the tool on page 1.)
- Report all potential and actual misconnections—even those that are caught before harm occurs—to the patient/medication safety officer, risk management, the device manufacturer, ISMP, and ECRI Institute. ISMP shares all reports with FDA, anonymously if desired.
- International Organization for Standardization (ISO). ISO 80369-1:2010. ISO 2010.
- ECRI Institute. Tracheal cuff inflation tube mistaken for enteral feeding tube. Health Devices. 1986;15(2-3):64-5.
- Anesthesia Patient Safety Foundation (APSF). IV connection to tracheostomy cuff inflation port reflects larger problem. APSF Newsletter. 2002;17(3).
- Infection Control Today. Joint Commission alerts organizations to tubing misconnection risks. August 20, 2014.
- ISMP. IV connection to tracheostomy cuff inflation port reflects a larger problem. ISMP Medication Safety Alert! 2001;6(24):1-2.
- Eakle M, Gallauresi BA, Morrison A. Luer-lock misconnects can be deadly. Nursing. 2005;35(9):73.
- FDA. Examples of medical device misconnections. December 13, 2017.
- The Joint Commission. Tubing misconnections—a persistent and potentially deadly occurrence. Sentinel Event Alert. 2006;(36):1-3.
- ISMP. Worth repeating… IV tubing misconnected to tracheostomy collar. ISMP Medication Safety Alert! 2007;12(12):1,3.