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Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive
The 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 therapy.
Use of the affected product may cause serious adverse health consequences, including those related to delay in initiation of therapy, over-delivery, interruption of therapy, or death.
At this time, there have been no reported injuries or deaths related to this issue.
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact ICU Medical Technical Support at 1-800-241-4002 and select option 3.
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