CareFusion, a medical device manufacturer based in San Diego, California, recently issued another warning for its Alaris infusion pumps. In the past year, the Alaris Infusion pump product line has experienced two recalls.
According to information from the company, the Alaris GP Infusion pumps may produce extremely small air bubbles as fluids move through the pump system. While the Alaris GP Infusion pump does have electronic detection tools to check for the presence of air bubbles, the system can’t detect extremely small air bubbles. Because of this, the extremely small air bubbles created by the pumps don’t trigger the detection and alarm system. If an air bubble is transferred into a patient’s circulatory system, an embolism may form.
The company first discovered the issue through its post-marketing surveillance program. The issue has also been noted by government health regulation agencies in Hong Kong. As of now, the company can not provide further details beyond those included in its warning letter. However, the warning letter confirmed that the Alaris GP Infusion pump is both sold and manufactured outside the United States.