Dive Brief:
- Smiths Medical has recalled nearly 86,000 Medfusion 3500 syringe pumps in the U.S. because of software issues that can cause the devices to fail.
- The Food and Drug Administration categorized the product correction as a Class I event in early February, reflecting the risk of serious injury or death, and published an alert Tuesday.
- Smiths Medical fixed the issues, which are linked to one reported injury, by updating its software. The company wrote to users in December, advising them to check they have the latest version.
Dive Insight:
Smiths Medical, which ICU Medical bought for $2.35 billion in January 2022, has faced a series of regulatory issues including a warning letter from the FDA in 2021.
The safety risks associated with the 3500 pumps discussed in the FDA alert were caused by old versions of the software. The problems relate to a high-priority alarm, incorrect parameters when infusions restart, screen lock issues, interruptions to delivery, the failure to pump at the minimum recommended rate and more, according to the FDA.
If undetected, the issues could cause the device to fail, delaying or interrupting therapy. Alternatively, the pump could deliver the therapy but fail to match the programmed setting.
The FDA issued a similar warning about more than 50,000 Smiths Medical Medfusion 4000 syringe pumps in February. Smiths Medical notified customers about the problems with the 3500 and 4000 devices on the same day in December. The FDA categorized the recalls for each version of the pump as Class I events at the start of February.
ICU Medical CEO Vivek Jain discussed the syringe pump business on a fourth-quarter results conference call last month. “Syringe pumps sold near normal quarterly levels but were down year-over-year, due to the higher shipments in Q4 of 2022 from the release of certain product holds,” Jain said.
Sales across the infusion systems business fell almost 4% in the fourth quarter compared to the prior-year period.
