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JANUARY 21, 2025

FDA Alert Highlights Smart Pump Software Anomalies

By SPC Staff

The FDA posted an alert noting that Fresenius Kabi USA has issued a letter to healthcare providers regarding a potentially high-risk infusion pump software issue. 

The letter recommended that customers update the Large Volume Pump software, version 5.9.2 and earlier, for its Ivenix Infusion System to version 5.10. The FDA said it is monitoring the issue and will provide updates as new information becomes available. 

“These anomalies have the potential to cause serious