FDA Safety Communication for Intravascular Air-in-Line and Air Embolism Risks Associated with Infusion Pumps, Fluid Warmers, and Rapid Infusers

PUBLISHED: Feb 5, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has issued a safety communication to provide important safety information and recommendations to help users of infusion pumps, rapid infusers, fluid warmers, and their accessory devices reduce the risk of air being introduced in a blood vessel (air-in-line) and air embolism associated with these devices. Air-in-line can be a potential risk to patients when fluids or medications are delivered into the body through a blood vessel. However, the clinical significance of air being infused into a blood vessel depends on several factors including the amount of air, how quickly the air is delivered, and specific patient factors like age, patient size and the overall health of the patient.

From January 2016 through December 2018, approximately three percent of Medical Device Reports (MDRs) associated with infusion pumps, rapid infusers, fluid warmers, and accessory devices describe events with air-in-line issues. The majority of the air-in-line issues involve malfunctions of the air-in-line alarm or error messages displayed by the device which did not cause patient injury. A small number of reports describe error messages which may have caused delays in therapy when critical medications were infused and/or potential air embolisms and patient deaths, some of which were reported to be confirmed by imaging.

Air-in-line issues are not specific to any manufacturer or model of device. Due to the limited information provided in these reports and the likely presence of significant comorbidities, it is often unclear if a correlation exists between the infusion pump, rapid infuser, fluid warmer, or their accessories and patient outcome. Often, devices are not returned to the manufacturer for further analysis, or accessory devices are discarded. MDRs are not, by themselves, definitive evidence of a faulty or defective medical device, and cannot be used to establish or compare rates of event occurrence.

FDA Recommendations:

To help reduce the likelihood of serious adverse events associated with air-in-line, the FDA recommends the following before, during, and after use of an infusion with a pump, rapid infuser, or fluid warmer:

Health Care Professionals

Plan Ahead

  • Train and educate health care professionals on the risk of air embolisms, ways to reduce the risk, and how to appropriately use infusion devices. For example:
  • Know whether the devices you use have an air-in-line sensor.
  • Be aware that some devices have programmable settings for air-in-line sensors, and the threshold of the sensor can be changed depending on the patient population being treated (for example, neonates, adults).
  • These settings should be checked to ensure they are appropriate for the patient population using the devices.
  • Be aware of recommended troubleshooting techniques when an air-in-line alarm occurs to prevent a delay of therapy.
  • Follow your institutional policies or consult the applicable device’s labeling (instructions for use) or the manufacturer for further information.
  • When priming accessory devices (such as IV tubing), follow the applicable manufacturer’s instructions for use to ensure the air is completely removed from the system.
  • Inspect devices before use, and do not use damaged devices. For example:
  • IV tubing should be free from damage such as cuts, kinks, or disconnections before and during use, as these can be a source of air in the tubing.
  • If a device is dropped, or appears damaged (for example, cracked), do not use it and remove it from service. Follow your institutions policy or return it to the manufacturer for evaluation.
  • If a patient is receiving a high-risk medication (for example, Epinephrine), be sure to have a backup plan in place. This may include having spare devices and accessories readily available.

Monitor

  • Recognize the signs and symptoms of an air embolism such as a sudden onset of chest pain or tightness, difficulty breathing or shortness of breath, lightheadedness, fainting, or confusion. In rare cases, this could include other neurologic symptoms. If a patient experiences a sudden onset of these symptoms, additional medical intervention (for example, rapid response team) may be needed.
  • If the air-in-line sensor on your device is not working properly (for example, false alarms or failure to alarm), remove the device from service, and follow your institutions policy which may include returning it to a biomedical department, or sending it to the manufacturer for evaluation.

Biomedical or Clinical Engineers

Plan Ahead

  • Be aware that some devices have programmable settings for air-in-line sensors, and the threshold of the sensor can be changed depending on the patient population being treated (for example, neonates, adults). These settings should be checked to ensure they are appropriate for the patient population using the device.
  • Follow your institutional policies or consult the applicable device’s labeling (instructions for use) or the manufacturer for further information.

Monitor

  • Conduct appropriate device maintenance in accordance with the manufacturer’s instructions to ensure proper functioning of the air-in-line sensors.
  • If a device is damaged and unable to be repaired by your facility, return it to the applicable manufacturer for evaluation and repair.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect an infusion pump, fluid warmer, rapid infusers or accessory devices are having problems such as, the pump showing signs of breakage or damage, including small chips or cracks, if an unexplained alarm occurs, or if the pump does not function as expected, file a voluntary report through the FDA’s MedWatch Program.

Included with today’s StayAlert! is a link to the FDA Safety Communication as well as example policies related to preventing air-in-line and air embolism.

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