CareFusion has announced a recall of the Alaris PC unit (model 8015) with software version 9.12 due to a communication error that occurs when the device is attached to the company's Alaris EtCO2 module (model 8300) or SpO2 modules (models 8210 and 8220). The unit was distributed between Sept. 21, 2012, and March 5, 2013.
According to customer reports, the PC Unit — a component of the Alaris infusion pump — has sounded an audible alarm and displayed a visual message indicating communication error when users switch between screens on the monitoring modules. While the unit's programmed infusions continue, all other actions are frozen except for the power-off button, and terminating infusions may have an adverse effect.
The company recommends discontinuing use of the device until the software is updated, or weighing the risks versus benefits before continuing its use.