FDA Issues Alert for Infusion Pump Software Glitch

The FDA has issued a correction regarding software version 5.10.2 for Fresenius Kabi's Ivenix Large Volume Infusion Pump. A software anomaly can cause the device to display incorrect battery health values and trigger false depletion alarms. This issue could lead to unexpected pump shutdowns, potentially interrupting or delaying critical patient therapy. The FDA recommends keeping affected pumps continuously plugged in until a software update becomes available.