Software issues lead Smiths Medical to recall over 85,000 infusion pumps

Software issues lead Smiths Medical to recall over 85,000 infusion pumps

Smiths Medical has been urging healthcare providers to update tens of thousands of its hospital syringe pumps after identifying issues with outdated software, and now the FDA is helping to get the word out.

Device correction notices were first sent out by the ICU Medical-owned Smiths in mid-December of last year. After categorizing the problem as a Class I recall in early February, the agency’s most serious label, the FDA published a new missive this week saying that the latest software versions prove to be a fix.

According to the agency, the effort includes more than 85,000 of the company’s Medfusion Model 3500 syringe pumps, distributed in the U.S. between 2002 and August of last year. Designed for administering a variety of fluids and therapies via several different delivery routes, the pumps are frequently seen in anesthesia and critical care settings, including neonatal and cardiac intensive care units.

The FDA said that software versions before v.6.0.0 could demonstrate several issues, such as high-priority alarms not sounding or the device restarting infusions with incorrect settings, locking its screen, incorrectly displaying bolus and loading dose information, or having doses fall below the minimum recommended rate, among others.

The agency said it has received one reported injury, and no deaths related to the pumps’ software.

At the same time as its Class I recall for the Model 3500, the FDA had also issued one for some 60,000 of Smiths’ Model 4000 pumps, over similar software issues previously flagged by the company; the agency said all those problems were also corrected in subsequent updates.

Previously, in late 2022, Smiths sent a letter to its customers detailing a pair of issues with more than 118,000 infusion sets used alongside its CADD line of portable pumps, including medication cartridges and tubing. According to the company, errors in manufacturing with spring-loaded pieces and false alarms on the pump could have interfered with fluid delivery.

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