Alaris Infusion Recall Issued Over Low Voltage Problem

A recall has been issued for Alaris infusion pumps after the manufacturer recognized that the pump may experience a loss of communication between the processor and the keyboard, which could result in an unexpected discontinuation of medication, posing serious adverse health consequences to users including death.  

The Alaris electronic infusion pump recall was announced by the U.S. Food and Drug Administration on June 17, which has categorized the action as a class I recall, meaning that the agency believes the problem has a high probability of causing serious injury or death.

According to the manufacturer, if the Alaris PC unit is held on 1.4 volts rather than 1.8 volts, it may cause a loss of communication between the PC Unit main processor and the keyboard processor. If a loss of communication occurs between the two processors than the pump may not administer the proper amount of fluid resulting in under treatment.

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Infusion pumps are used for administering controlled amounts of medications or other fluids to patients intravenously, intra-arterially, through epidural, and other commonly acceptable methods of administration. The pumps can become extremely hazardous to users if there is a malfunction that disrupts the quantity of medication being administered which may lead to overdose or under treatment.

The Alaris infusion pump recall includes the 8015 model containing the 9.12 software version. These pumps were manufactured by CareFusion Corporation of San Diego, California and distributed from September 21, 2012 through May 17, 2013 nationwide.

In the event of a communication error the Alaris PC unit will display either a “SYSTEM ERROR” or “CHANNEL DISCONNECTED” error message on the screen and disallow the user to use the “PAUSE” or “SILENCE” keys. The FDA is warning users that during the loss of communication, if the “SYSTEM ON” key is pressed it will result in termination of all infusions and could lead to serious injury or death.

The FDA is advising users to either stop using the affected Alaris infusion pump or to adopt the following recommendations. Fully charge the units prior to use, keep the unit plugged in at all times, and store a back-up infusion pump at all times. Users may continue to use the affected infusion pumps unless a programming change in required.

CareFusion is attempting to reach out to all customers who may have the affected infusion pumps within 60 days to update and correct the voltage on the keyboard processor. Users should contact CareFusion at 1-888-812-3266 if the pump displays a “SYSTEM ERROR” or a CHANNELL DISCONNECTED” message.


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