The article discusses a Class I recall affecting Model 4000 syringe pumps distributed between November 2010 and July 2023. These pumps are used in healthcare settings for administering various fluids, including blood and drugs. The recall was issued due to software issues in earlier versions that could potentially disrupt the alarm system, pump functions, and control screen, leading to delayed or interrupted therapy. The FDA warned that these faults could result in serious harm or death.
Smiths Medical, the manufacturer, has addressed these issues in subsequent software updates and advised users to install the latest Medfusion software on their pumps. This recall, impacting over 60,000 devices globally, is part of a series of regulatory actions concerning the Medfusion pump line. The FDA had previously issued a warning letter in 2021 for failures in reporting issues and validating software and design changes.
The article also mentions that ICU Medical, which includes the syringe and inventory pump products, experienced an 8% sales decline in its infusion systems unit, totaling $149 million. Despite this, the CEO, Vivek Jain, noted some improvement in the unit compared to previous years, though it still lags behind pre-COVID levels. Jain emphasized the importance of consistent improvement across all units and acknowledged the challenges faced, including broader supply chain issues and costs associated with addressing these problems.