FDA Safety Communication: Intravascular air-in-line and air embolism risks associated with infusion pumps, fluid warmers, and rapid infusers
The FDA is providing 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.
An infusion pump delivers fluids or medications, into a patient’s body in controlled amounts. Infusion pumps are commonly use in hospitals and other healthcare settings by healthcare professionals but can also be used by patients and caregivers at home.
A fluid warmer electrically warms fluids or blood products before they are given to a patient intravenously to help the patient maintain a normal body temperature. Fluid Warmers are generally used by trained health care professionals in a hospital or clinical setting for trauma or surgical patients.
A rapid infuser is used to administer blood products and fluids at rapid rates to critically ill patients. They are generally used in a hospital or clinical setting by trained healthcare professionals.
Accessory devices include intravenous (IV) tubing or administration sets. The tubing is inserted into the medication or fluid container, which runs through an infusion pump, fluid warmer, or rapid infuser, and into the patient’s blood vessel through a catheter or port.
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,
- specific patient factors (for example, patient age, patient size, the overall health of the patient).
If a significant amount of air is introduced into a blood vessel, it can travel through the blood vessels and become lodged in critical organs such as the brain, heart, or lungs. This is known as an “air embolism,” which can be life threatening because it may prevent oxygen from reaching those critical organs. Without oxygen, the tissues or organs become damaged.
As medical device technology continues to evolve, many devices used for infusions now have air-in-line sensors. When the device detects or senses air in the IV tubing, the device typically stops infusing, and generates an audible and/or visual alarm to alert the device user. These alarm sensors help prevent and reduce the risk of air embolism. As with any technology, sometimes these sensors or alarms can malfunction or fail for various reasons (for example, lack of proper device maintenance, damaged device, if air enters damaged IV tubing below where the device detects air in the line, if the air-in-line sensor has debris on it, etc.).
While air-in-line sensors are meant to prevent, or reduce the risk of air embolisms, there can sometimes be false alarms or nuisance alarms. With a false alarm, the device may generate an air-in-line alarm when air is not present, or the amount of air detected is so small that it would not present a risk to the patient. When the device alarms, it stops the infusion, which may cause delays or an interruption of therapy.
When a device stops infusing, this could be problematic if critical medications (for example, Epinephrine) are being infused. Some infusion devices offer different ranges or thresholds of air-in-line detection, which can be adjusted depending on the patient population. For example, an infusion pump air-in-line sensor setting used in a neonatal or pediatric patient population would likely be more sensitive than an adult patient population due to the patient size differences. In general, the setting of the air-in-line detector should be considered so that it is sensitive enough to help prevent a harmful amount of air reaching the patient, but not so sensitive that it generates false alarms too frequently.
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
- 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 recommends that you Plan Ahead (for example, know how to use the device properly, and have a backup plan) and Monitor (for example, inspect and maintain the device, and watch for patient signs or symptoms). To help reduce the likelihood of serious adverse events associated with air-in-line, FDA recommends the following before, during, and after use of an infusion with a pump, rapid infuser, or fluid warmer.
