Intravenous products: The FDA safety information and adverse event reporting program from MedWatch have reported on the potential for delay or interruption of therapy with the Â CareFusion Alaris infusion pumps (Model 8015).
ISSUE: Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions.
If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy. This could lead to serious injury and/or death. These devices were manufactured from December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010.
BACKGROUND: Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
RECOMMENDATION: If users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately. The corrective action will require a hardware update to all affected units. CareFusion does not require that the devices be returned.