Misconnection of Devices to IV Tubing Can Be Fatal

The FDA recently added a case case to its Examples of Medical Device Misconnections webpage, about an event in which a pneumatic (air inflation under pressure) tubing line from a noninvasive vascular diagnostic system was erroneously connected to an intravenous (IV) catheter.¹ The case was reported to the FDA this year.

An ultrasonography is performed using a noninvasive vascular diagnostic system. The procedure may involve obtaining a blood pressure (BP) measurement to assess the arterial BP differences between a patient’s arms and legs. As in the case shared by the FDA, the pneumatic tubing used to inflate the cuff during the procedure had a Luer connector that was compatible with the patient’s IV catheter (Figure²). The connector was erroneously attached to the patient’s IV catheter. As a result, a technician in training injected air into the IV line, and the patient died from an air embolism.

Figure

In June 2003, the Institute for Safe Medication Practices (ISMP) showed how BP monitor tubing (left) could connect to either BP cuff tubing (top) or the Y-site of IV tubing (bottom) that was used at the time. Note how similar in appearance the IV tubing (with propofol) is to the BP cuff tubing.²

This latest case is like others about which the ISMP has written. In one case, tubing from a portable BP monitoring device was inadvertently connected to the patient’s IV line, causing a fatal air embolism.³ In another case, an air supply hose from a sequential compression device (SCD), also referred to as an intermittent pneumatic compression device, was inadvertently connected to a needleless IV tubing port. Thankfully, the mistake was discovered and the SCD turned off before any patient harm occurred.¹

The best solution is to eliminate interconnectivity between various medical tubing connections. International Organization for Standardization (ISO) standard 80369 addresses connectors that allow the pneumatic flow of gases via a limb cuff connection (eg, SCDs, pneumatic tubes to BP cuffs). This is the same standard that addresses misconnections with enteral, neuraxial, and vascular connectors (Luer). The FDA has evaluated the recognized standards, and manufacturers are encouraged to apply the standards to medical devices, as appropriate.

Although connections between pneumatic and vascular systems may be rare, some misconnections are corrected before serious injury occurs, and not all incidents (close calls) may be reported to the FDA. Misconnections can happen with devices that have not incorporated connector designs conforming to new standards, according to the FDA. Therefore, the Emergency Care Research Institute, the FDA, and the ISMP encourage providers to report incidents, even if the misconnection was corrected before reaching the patient.

In addition, the FDA says it will continue to work with advocacy groups, federal partners, manufacturers, patients, professional societies, standards organizations, and other stakeholders to reduce the chance of medical device misconnections and patient harm.⁴ Perhaps the FDA could help move this along by developing guidance for the industry that more formally requires the use of the ISO standard when medical devices are manufactured.

Meanwhile, to protect patients, this issue demands attention. Work with biomedical engi-neering to seek out medical equipment that will not connect to vascular systems. When possible, place BP cuffs on a different limb from an IV site and remove IV catheters once they are no longer needed. Appropriately labeled IV lines could help alert staff members if they are about to access that line accidentally. Educate staff members, including non-clinical employees who work in patient care areas, about this hazard. Before any tubing is connected or reconnected to a patient, verify the access point and trace the line toward the insertion site/cuff.

Although trained, licensed practitioners can inadvertently connect the wrong type of tubing to an IV line, especially in a rushed environment or when their view is obstructed, recognize that unlicensed, untrained staff members may disconnect or reconnect various tubing or be inappropriately asked to perform specific tasks, such as turning off pumps before patient transport.

During orientation, and when possible, educate unlicensed staff members about these risks and tell them to refuse requests to connect or disconnect medical tubing.

References

1. Examples of medical device misconnections. FDA. February 23, 2023. Accessed April 4, 2023. www.fda.gov/medical-devices/ medical-device-connectors/examples-medical-device-misconnections

2. Blood pressure monitor tubing may connect to IV ports. Institute for Safe Medication Practices. June 12, 2003. Accessed April 28, 2023. www.ismp.org/resources/blood-pressure-monitor-tubing-may-connect-iv-ports

3. Problems persist with life-threatening tubing misconnections. Institute for Safe Medication Practices. June 17, 2004. Accessed April 28, 2023. https://www.ismp.org/resources/problems- persist-life-threatening-tubing-misconnections

4. Reducing risks through standards development for medical device connectors. FDA. November 7, 2022. Accessed April 4, 2023. www.fda.gov/medical-devices/medical-device-connectors/reducing-risks-through-standards-development-medical- device-connectors

About the Author

Michael J. Gaunt, PharmD, is a senior director of error reporting programs and editor at the Institute for Safe Medication Practices (ISMP) in Horsham, Pennsylvania. He also serves as the editor of the monthly ISMP Medication Safety Alert! Community/Ambulatory Care newsletter.