Tracheal Cuff Inflation Tube Mistaken for Enteral Feeding Tube
Hazard [Health Devices Feb-Mar 1986;15(2-3):64-5]
A member hospital reported that an enteral pump set
was inadvertently connected to the cuff inflation tube (pilot tube) of a cuffed endotracheal
tube. The female connector of the pilot tube is similar in shape and color to the
connector of the feeding tube that was used on the patient. The enteral formula
overinflated the endotracheal tube cuff, completely occluding the tracheal tube. The
ventilator alarmed, and the patient suffered respiratory arrest. Fortunately, the patient
survived. While less likely, similar misconnections are also possible with other tracheal
tubes that have a female connector that is compatible with a male Luer connector. For
example, IV pumps could also be misconnected to almost any pilot tube.
The style of involved tracheal tubes (both endotracheal
and tracheostomy) have a cuff made of polyurethane foam encapsulated in a silicone
elastomer balloon. Before inserting the tracheal tube into the trachea, the user deflates the
foam by applying vacuum to the pilot tube. After insertion, the user releases the vacuum,
and the cuff passively expands to the desired size at atmospheric pressure. This design
is intended to prevent tracheal injury caused by cuff overpressurization and eliminate
the risk of deflation associated with inflatable cuff designs. Although it is not intended
to be an inflatable cuff, the foam encapsulated cuffs will expand well beyond their
normal size when overpressurized. The pressure generated by any enteral feeding pump is
sufficient to overinflate such cuffs.
The no-flow alarm systems on currently available enteral pumps will not
detect a misconnection to a tracheal tube cuff as long as the cuff can expand. Depending
on its elasticity, the cuff could expand enough to occlude the patient's airway or burst
before an enteral pump would alarm. Similarly, many IV pumps probably would not alarm soon
enough to avoid patient injury.
For mechanically ventilated patients, the ventilator's high-pressure or
low-exhaled-volume alarm should detect airway occlusion caused by an overinflated cuff,
but only if its limits are set correctly. An overinflated cuff can also impede exhalation,
resulting in dangerously high peak-inspiratory and end-expiratory pressures, which can
cause severe cardiopulmonary complications. Intubated patients that are not mechanically
ventilated, and therefore are not protected by ventilator alarms, would most likely
suffocate if the cuff were sufficiently overinflated to occlude the airway.
In this incident, the male connector on the enteral pump
set and the female connector on the cuff pilot tube were both red. Although the
female connector on the feeding tube is pink, it appears almost identical to the female
connector on the endotracheal tube. Therefore, it is possible to mistake the pilot tube connector
for the feeding tube connector. Also, because the pilot tube is usually not capped, it
invites the insertion of a compatible male connector, especially when the connectors
happen to be the same color. Unfortunately, no color coding standards exist to help
We believe that misconnections of enteral and IV solution delivery sets to
pilot tube connectors of other tracheal tubes may be nearly as likely as the specific
incident described because all of these connectors are Luer compatible. Syringes with Luer
connectors are necessary to irrigate feeding tubes, administer enteral formula, inflate
tracheal tube cuffs, and access the bloodstream. For this reason, the connectors of these
fluid delivery products are manufactured to be compatible with the male Luer connector of
the syringes. Thus, most parenteral or enteral administration sets can be connected to
most IV, enteral, tracheal tube, or urinary catheters. In one case, an enteral
administration set was misconnected to an IV catheter, resulting in the patient's death.
We believe that manufacturers have been slow in developing connectors and
that standards committees have been slow in developing related standards for parenteral,
enteral, urinary, and respiratory products that would make these connectors incompatible
with one another but compatible with a tapered Luer. Considering the huge investment in
manufacturing parenteral products and the growing investment in manufacturing enteral
products, we believe that design efforts to ensure protective incompatibility between
parenteral and enteral products should be given high priority by manufacturers.
Undoubtedly, the burden is on the user to trace every fluid delivery line,
whether gas or liquid, from the patient to its respective source to prevent
misconnections. However, we believe that the existing connector compatibility invites
- Alert users to the risk of misconnecting a pump set
(e.g., enteral or IV) to the inflation tube of a tracheal tube cuff or any
other Luer receiver.
- Whenever possible, position catheters, feeding
tubes, and pilot tubes exiting from the patient on different sides of the
patient's body. Position the respective delivery system on the same side of
the patient from which the catheter exits.
- Always trace fluid delivery lines from their
respective sources before making connections.
- When the possibility for misconnection exists,
affix labels to the catheters and administration sets.
- Always properly adjust ventilator alarm limits.
- Encourage manufacturers to supply these products with connectors that
cannot be misconnected.
- Cuffs, Tracheal Tube [14-082]
- Cuffs, Tracheostomy Tube [14-094]
- Enteral Feeding Kits [11-677]
- Tubes, Feeding [14-199]
- Tubes, Tracheal [14-085]
- Tubes, Tracheostomy [14-096]
Cause of Device-Related Incident
Device factors: Design/labeling error; Device interaction
User error: Accidental misconnection
Mechanism of Injury or Death