The FDA has issued a notice about a recall of components of the Alaris PC unit (model 8015), part of the Alaris electronic infusion pump, which delivers controlled amounts of medications or other fluids through IV, IA, epidural and other routes of administration.
The manufacturer, CareFusion Corporation, has received reports of customers experiencing a communication error on the Alaris PC unit with software version 9.12 when attached to the Alaris EtCO2 module (8300) or the Alaris SpO2 module (models 8210 and 8220). The firm has sent a recall notification letter to affected customers.
While toggling between the Alaris EtCO2 Main Screen, displaying the Capnography waveform, and the EtCO2 Limits screen, the Alaris PC unit may experience a communication error. The error also can be experienced while toggling between the Alaris SpO2 Main Screen, displaying the Pleth waveform, and the SpO2 Limits screen. The Alaris PC unit will produce an audible alarm and the attached modules will display a Communications Error message with a flashing red light.
When the Alaris PC unit experiences a communication error, the infusions will continue as programmed. However, no further key presses on the Alaris PC unit will have an effect on the system except for the System On key, which allows the user to power down the device. Powering down of the device results in termination of all infusions. Termination of an infusion could result in serious injury or death.
The recall is a Class I, meaning there is a reasonable possibility that use of the product will result in serious adverse health consequences or death.
The FDA recommends either discontinuing the use of the EtCO2 or SpO2 modules until the correction has been implemented by CareFusion, or weighing the risk/benefit to patients before continuing to use those modules. Anyone who experiences a communication error on the Alaris PC unit may contact CareFusion Customer Advocacy at 888-312-3266, 24 hours a day, or via email at email@example.com
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