CareFusion Alaris PC unit (model 8015) Class I Recall – Potential loss of communication between processor and keyboard


Intravenous products: FDA report “CareFusion has reported that if the Alaris PC unit model 8015 voltage is 1.4 volts, rather than the 1.8 volts required for operation, the device could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor. A device malfunction can result in the sudden unintended discontinuation of medications.

When the Alaris PC unit model 8015 experiences a communication error, the unit will display either a “SYSTEM ERROR” or “CHANNEL DISCONNECTED” error message. During the communication error, the programmed infusion(s) will run as previously programmed; however no further key presses on the Alaris PC unit have an effect on the system, including “PAUSE” and “SILENCE” keys. The user may terminate all infusions by pressing the “SYSTEM ON” key. Termination of an infusion could result in serious injury or death.”

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