ICU Medical issues infusion pump software correction

Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive

The U.S. Food and Drug Administration (FDA) is aware that ICU Medical has sent all affected customers an Urgent Medical Device Correction for the Plum Duo Infusion System due to the pump software possibly resulting in the pump becoming unresponsive. Pumps may experience two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. This may result in delay of therapy or interruption of therap…

ICU Medical issues infusion pump software correction

The Plum Duo infusion pump system. [Image from ICU Medical/FDA]The FDA issued a notice labeling a recall of ICU Medical (Nasdaq: ICUI) infusion pumps as the most serious type of recall. This recall involves correcting certain devices. It does not require removing them from where they are used or sold. However, the FDA identified that the issue may cause serious injury or death if the customer fails to make the necessary correction. ICU Medical i…