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Class I Medical Device Recall: CareFusion Corporation, Alaris PC Units (Model 8015)

Fri, 10/15/2010 - 8:30am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: July 13, 2010

Product: Alaris PC unit (model 8015)

The Alaris PC Unit Model 8000 is NOT affected by this recall.

The affected serial numbers are found on the company’s website. See below under Useful Links.

These devices were manufactured from December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010.

Use: Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

Recalling Firm:

CareFusion Corporation

10020 Pacific Mesa Boulevard

San Diego, California 92121

Reason for Recall:

Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions.

If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy. This could lead to serious injury and/or death.

Public Contact:

Customers may contact the company at their CareFusion Recall Support Center, Monday through Friday, 7 AM through 4 PM Pacific Time, at 1-888-562-6018 or by email at SupportCenter@carefusion.com

FDA District: Los Angeles

FDA Comments:

On August 24, 2010, CareFusion sent their customers using the affected Alaris PC Units a recall notification letter with a Response Card by registered mail. Customers were required to confirm receipt of the notice by returning the Recall Response Card, by FAX or mail.

The recall notice informed the customers of the reason for the recall, the units affected, the potential risk, a step-by-step description of the issue, and the required actions for users. CareFusion will contact the affected facilities by phone or in person within 60 days of receipt of the recall notice to initiate corrective action. The corrective action will require a hardware update to all affected units. CareFusion does not require that the devices be returned.

Until corrective action is taken, if users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately.

Class 1 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 FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links:

    

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