Dive Brief:
Smiths Medical has issued a recall for its CADD-Solis ambulatory infusion pumps due to several issues associated with outdated software, as announced by the Food and Drug Administration (FDA) on Tuesday. The reported problems include the devices failing to emit necessary alarms, unresponsive stop and power keys, and the inadvertent exposure of passwords to individuals accessing certain files.
Despite addressing many of these issues in prior software updates—an action communicated through an urgent notice back in February—ICU Medical, the current owner of Smiths Medical, has opted to keep the devices on the market. The FDA has disclosed one injury connected to these issues but no deaths.
Dive Insight:
The acquisition of CADD-Solis came as part of ICU Medical’s takeover of Smiths Medical which was finalized in early 2022, for a sum of $2.35 billion. Since then, ICU Medical has faced several challenges with Smiths Medical’s portfolio, including previous recalls, warning letters, and declining sales.
CADD-Solis infusion pumps are designed for ambulatory use, allowing patients the freedom to move around while receiving infusions either at home or in clinical settings. Earlier issues centered around syringe pumps, but the current focus is on the ambulatory pumps after a thorough review conducted by Smiths Medical. The company reevaluated its historical risk assessments undertaken during its software development phases, revealing eight significant problems.
The review highlighted deficiencies in the original risk evaluations concerning the adequacy in addressing potential risks. As a response, Smiths Medical decided that, despite available solutions from earlier software updates, the severity of the identified risks warranted an urgent notification to the healthcare community.
This initiative took form in a medical device correction notice issued in February, although, at that time, Smiths had not documented any serious injuries or fatalities linked to the defects. However, the recent FDA announcement, classified as a Class I recall—indicating a situation where there is a reasonable probability of serious health consequences or death—has acknowledged one injury associated with the pumps.
During a recent earnings call, an analyst hinted at a potential turnaround for the troubled Smiths Medical division, suggesting that some negative aspects “feel like they’re turning positive.” In response, ICU Medical CEO Vivek Jain acknowledged the improved sales performance of the Smiths portfolio. He noted it was the best quarter since addressing the backlog issues. However, Jain remained cautiously optimistic, emphasizing that while there have been positive steps, substantial improvements are still necessary.
This situation underscores the ongoing challenges faced by ICU Medical in integrating and optimizing the Smiths Medical portfolio, reflecting broader issues of ensuring safety and efficacy in medical device software management and oversight.
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