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Class 1 Recall Issued for CareFusion Corporation's - Alaris PC Unit (Model 8015) With Version 9.12 Keyboard Processor


8/8/2013 7:50:02 AM

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CareFusion – Alaris PC unit (model 8015) with version 9.12 Keyboard Processor

Recall Class: Class I

Date Recall Initiated: June 17, 2013

Product: Alaris PC unit model 8015 with software version 9.12

The affected products were distributed from Sept. 21, 2012 through May 17, 2013.

Product Codes and Lot Numbers: Serial Numbers List disclaimer icon

Use: The Alaris PC unit (model 8015) is part of the Alaris electronic infusion pump. An electronic infusion pump delivers controlled amounts of medications or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

Recalling Firm:

CareFusion Corporation

3750 Torrey View Ct

San Diego, California 92130

Reason for Recall: 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. This can lead to cause serious adverse health consequences, including death.

Public Contact: For questions about this recall, customers may contact the CareFusion Recall Support Center at 1-888-562-6018, Monday through Friday, 7:00 AM to 4 PM, Pacific Time or by email at SupportCenter@carefusion.com.

FDA District: Los Angeles District Office

FDA Comments: On June 17, 2013, CareFusion issued an Urgent Medical Device Recall to all affected customers with required actions for users. These actions are listed below in the "Required Actions for Users" section.

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.

Required Action for Users:

Weigh the risk/benefit to patients before continuing to use Alaris PC Unit (model 8015) with version 9.12.

Either stop using the affected Alaris PC Unit (model 8015) until the correction has been implemented by CareFusion, or continue to use on patients and follow steps 2 through 5.

Fully charge Alaris PC units prior to use

During operation and when not in transport, keep Alaris PC units plugged in at all times

Consider having additional back up Alaris PC Units available

If you experience the described error code messages on the Alaris PC unit during infusion, you may continue the infusion(s) as programmed unless a programming change is required. Obtain a back-up Alaris PC unit to replace the device.

If you experience a "SYSTEM ERROR" (111.2000 or 111.2002), or a "CHANNEL DISCONNECTED" error on the Alaris PC unit (model 8015), contact CareFusion Customer Advocacy at 1-888-812-3266, 24 hours a day, 7 days a week or by email at customerfeedback@carefusion.com.

Action by CareFusion:

A CareFusion representative will contact all affected customers within 60 days to provide an update to correct the voltage on the keyboard processor.

CareFusion does not require customers to return their devices.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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