Alaris Infusion Pump PC Units Recall Due to Software Errors

A class 1 recall has been issued for the Alaris Electronic Infusion Pump, which includes two different pump module attachments that may cause the pump unit to experience communication errors and malfunction.

CareFusion Corporation, based in San Diego, CA, recalled the Alaris PC Unit Model 8015 with software version 9.12 when the Alaris EtCO2 or SpO2 modules are connected to the unit.

The action was taken after customers reported experiencing communication problems when toggling between the EtCO2 main screen and the EtCO2 limits screen. The toggling causes the Alaris PC Unit to experience a communication error that could result in severe and potentially fatal injuries.

The units, which were distributed between Sept 21, 2012 and March 5, 2013, also experience communication errors while toggling back and forth between the SpO2 main screen and the SpO2 limits screen.

Infusion pumps are medical devises which deliver medication and other fluids to the body. Various types of pumps can deliver medication intravenously, subcutaneously, intra-arterially or through epidural infusion. The pumps are often worn by Type 1 diabetics to deliver insulin. Infusion pumps are also used in hospital settings to deliver different fluids, including chemotherapy, antibiotics and anesthesia.

The Alaris unit will produce an alarm accompanied by a flashing red light and a communications error message when a problem occurs. During this time, the programmed infusions will continue to operate correctly, but no other options will operate, except for the System On key.

The System On key powers down the unit. Powering down the unit at this time can terminate all scheduled infusions, which may result in serious injury or death from a lack of needed and scheduled medication.

A class 1 recall is the most serious type of medical device recall issued. It is only issued when there may be potential for the product in question to cause serious adverse side effects or death. There are no reported cases of serious injury or death related to the class 1 recall of the Alaris Infusion Pump at this time.

Amid a number of problems with infusion pumps in recent years, which have resulted in a number of recalls, the FDA issued new guidance for the pumps in 2010. The guidance was an attempt to increase quality and safety by requiring manufacturers to conduct more risk assessments before receiving approval for the new or modified pump.

As part of the guidance, manufacturers were required to submit additional design and engineering information before receiving premarket approval.

Officials recommend customers discontinue use of the pump until a correction can be made. Users who continue using the pumps are strongly cautioned to weigh the benefits against the risks before continuing use.

CareFusion is requiring all customers to confirm receipt of the recall notification by returning the recall response card. A representative will then contact the customer to schedule a software upgrade. Returning the equipment is not necessary. Customers can call the CareFusion Recall Support Center at (888) 562-6018 or email SupportCenter@carefusion.com.