Intrapulmonary Feeding Tubes With an Electromagnetic Device

Abstract and Introduction

Abstract

Background: Intrapulmonary placements of feeding tubes inserted with use of an electromagnetic placement device (EMPD) continue to occur.

Objective: To describe circumstances and outcomes associated with intrapulmonary feeding tube placements during use of an EMPD.

Methods: A retrospective review of reports to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database of intrapulmonary feeding tube placements during use of an EMPD from 2019 through 2021. Complications, outcomes, operator training, interference from anatomical variations and medical devices, and the use and accuracy of radiographs in identifying pulmonary placements were recorded.

Results: Sixty-two cases of intrapulmonary tube placement were identified; 10 were associated with a fatal outcome. Pneumothorax occurred in 35 cases and feedings were delivered into the lung in 11 cases. User error was cited in 6 cases and was implicit in most others. Little information was provided about operator training. Four intra pulmonary placements were associated with anatomical variations and 1 with a left ventricular assist device. Radiographic follow-up was described in 28 cases and correctly identified 23 of the intrapulmonary placements.

Conclusions: User error was a significant factor, which highlights the need for empirical data to clarify the amount of training needed to safely credential EMPD operators. Clearer information is needed about anatomical variations that may contraindicate use of an EMPD, as well as medical devices that may interfere with an EMPD. Use of follow-up radiographs, interpreted by qualified personnel, is supported to increase the probability of identifying intrapulmonary tube placements.

Introduction

Risk for intrapulmonary placement of feeding tubes is a major concern, especially during blind insertions. For this reason, some institutions elect to use an electromagnetic placement device (EMPD) to track and display the path of a feeding tube during its insertion. The EMPD discussed in this article is the Cortrak* 2 Enteral Access System from Avanos Medical, Inc.

An adequately trained operator using an EMPD properly can recognize when a tube deviates into a proximal airway before a lung placement occurs.^[1] However, despite multiple reports in which EMPD operators successfully avoided intrapulmonary tube placements,^[1–3] undetected misplacements continue to be reported to the US Food and Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database.^[4–7]

A number of factors can contribute to failure to detect intrapulmonary tube placements during use of an EMPD; however, given the complexity of interpreting EMPD tracings, the most likely cause is inadequate operator training. Other factors may include variations in gastrointestinal anatomy and electromagnetic interference from other electrical equipment used in close proximity to the EMPD. The extent to which these factors affect undetected intrapulmonary placements with EMPDs is unclear.

Despite reports that highly trained EMPD operators can avoid intra pulmonary tube placements, undetected misplacements continue to be reported to the MAUDE database.

The FDA recommends that use of an EMPD be limited to clinical staff who have received the prerequisite training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube.^[8] The FDA also recommends that determination of final tube location be made according to policies at the institution where the EMPD is used.^[8] Thus, some facilities may require radiographic follow-up after all EMPD-guided tube insertions, whereas others may use radiographic follow-up only sporadically.

The objective of this study was to describe circumstances associated with undetected intrapulmonary feeding tube placements during use of the Cortrak* 2 Enteral Access System (referred to as an EMPD) reported in the MAUDE database during a 3-year period (2019–2021).

Table 1. Descriptive data for intrapulmonary feeding tube placements (N = 62)
Variable	No. of cases
Tube site
Lung (unspecified)	29
Right lung only	21
Left lung only	11
Right and left lung	1
Complications
Pneumothorax	35
Delivery of feedings into lung	11
Cardiac arrest	1
No change in status	5
No information	10
Outcome
Survived	52
Died	10
Radiographic results after initial tube insertions
Accurate	23
Inaccurate	5
Not used	7
No information	27
Information about training
Training documented as having been received	6
No information	56
User error explicitly acknowledged in report
Yes	6
No	56
Anatomical variations associated with misplacements
Scoliosis	1
Kyphosis	1
Patient anatomy, not defined	2
No information	58
Medical device that could interfere with Cortrak system
Left ventricular assist device	1
No information	61

Table 2. Ten cases with fatal outcomes
Problem(s)	Description
Pneumothorax	Case 5: An erroneous tube placement in the right lung was not identified by the EMPD operator; however, it was identified by follow-up radiography. Upon removal of the tube, the patient's lung deflated and death occurred within hours. Case 39: An erroneous tube placement in the right lung was not identified by the EMPD operator; several hours later, the patient became agitated. A radiograph at this time confirmed a pneumothorax. It was later noted that the EMPD tracing showed that the "tube was obviously going toward the right lung." The patient had previously been intubated because of end-stage chronic obstructive pulmonary disease. Death was reported to result from issues unrelated to the pneumothorax. Case 8: An erroneous tube placement in the right lung was not identified by the EMPD operator; no information was available about radiographic follow-up of tube location. The report indicated that many circumstances contributed to the death.
Pneumothorax and delivery of feeding into lung	Case 2: An erroneous tube placement in the left lung was not identified by the EMPD operator or on a follow-up radiograph. The patient's nurse noticed the problem when formula was seen coming out of a chest tube placed for reasons unrelated to the feeding tube. At that time, a computed tomography scan of the chest was obtained, which showed the feeding tube in the left lung, along with a pleural effusion. The patient, who was terminally ill, died. Case 58: An erroneous tube placement in the left lung was not identified by the EMPD operator, nor on a follow-up radiograph. Liquid morphine was administered via the tube, along with liquid feed at a rate of 25 mL/h. When the patient later complained of severe pain in her left side, a second radiograph was obtained, which showed the tube in the lung. The tube was immediately removed. Two days later, the patient developed respiratory failure and was transferred to an intensive care unit, where she was intubated and a chest tube was placed. She ultimately developed sepsis and died.
Delivery of feeding into lung	Cases 49, 51, 54, and 55: These 4 cases involved intrapulmonary tube placements not identified by EMPD operators. Follow-up radiographs were not used. The patients ultimately developed pneumonia and died. No other information was provided.
Lung placement	Case 18: Death occurred after a "lung placement" that was not identified by the EMPD operator. No other information was provided.

Table 2. Ten cases with fatal outcomes

Problem(s)

Description

Pneumothorax

Case 5: An erroneous tube placement in the right lung was not identified by the EMPD operator; however, it was identified by follow-up radiography. Upon removal of the tube, the patient's lung deflated and death occurred within hours.
Case 39: An erroneous tube placement in the right lung was not identified by the EMPD operator; several hours later, the patient became agitated. A radiograph at this time confirmed a pneumothorax. It was later noted that the EMPD tracing showed that the "tube was obviously going toward the right lung." The patient had previously been intubated because of end-stage chronic obstructive pulmonary disease. Death was reported to result from issues unrelated to the pneumothorax.
Case 8: An erroneous tube placement in the right lung was not identified by the EMPD operator; no information was available about radiographic follow-up of tube location. The report indicated that many circumstances contributed to the death.

Pneumothorax and delivery of feeding into lung

Case 2: An erroneous tube placement in the left lung was not identified by the EMPD operator or on a follow-up radiograph. The patient's nurse noticed the problem when formula was seen coming out of a chest tube placed for reasons unrelated to the feeding tube. At that time, a computed tomography scan of the chest was obtained, which showed the feeding tube in the left lung, along with a pleural effusion. The patient, who was terminally ill, died.
Case 58: An erroneous tube placement in the left lung was not identified by the EMPD operator, nor on a follow-up radiograph. Liquid morphine was administered via the tube, along with liquid feed at a rate of 25 mL/h. When the patient later complained of severe pain in her left side, a second radiograph was obtained, which showed the tube in the lung. The tube was immediately removed. Two days later, the patient developed respiratory failure and was transferred to an intensive care unit, where she was intubated and a chest tube was placed. She ultimately developed sepsis and died.

Delivery of feeding into lung

Cases 49, 51, 54, and 55: These 4 cases involved intrapulmonary tube placements not identified by EMPD operators. Follow-up radiographs were not used. The patients ultimately developed pneumonia and died. No other information was provided.

Lung placement

Case 18: Death occurred after a "lung placement" that was not identified by the EMPD operator. No other information was provided.