Cardinal Health, Inc. has issued an urgent safety warning regarding its Alaris PC & PCA Infusion devices which can potentially infuse above or below the intended infusion dose in certain cases. This is the latest in a string of warnings from the company about the safety of its products.

Details of Cardinal’s warning

According to Cardinal Health’s website, the company’s infusion pumps are supposed to provide patients with controlled amounts of medications and fluids intravenously via a wireless computer connection. However, a software glitch with its Alaris PCA and PC devices, coupled with other factors, can cause patients serious injury or even death.

Specifically, when the Alaris PCA (patient controlled analgesia) module, model 8120, is used with the Alaris PC unit, models 8000 and 8015 with software versions 8 through 9.1, the PCA module can potentially infuse above or below the intended infusion dose when five specific events occur.

The company issued the safety warning after receiving information from two patients on the issue and plans to fix the software by April 2009 subject to a consent decree between the company and the U.S. Food & Drug Administration (FDA). Only the Alaris PCA and PC units are the subject of the latest safety warning.

The latest in a string of warnings

This latest warning is not the only safety issue facing Cardinal and its infusion devices. Cardinal recalled its Alaris SE infusion pumps in 2006 after it was discovered that some of the pump’s keypads were defectively designed and could cause over-infusion. The FDA investigated the matter and found that certain of the Cardinal’s infusion pumps did not meet safety standards of the Federal Food, Drug & Cosmetic Act and seized the defective products from Cardinal.

The company has been operating under an FDA consent decree since February 2007 in connection with its Alaris SE infusion pumps. Under that agreement, the company is supposed to review its full line of infusion pumps and submit a corrective action plan to the FDA shortly.

If you’ve been injured due to one of Cardinal’s defective infusion pumps, contact an experienced product liability attorney to discuss your situation and evaluate your options. Consultations are free, without obligation and are strictly confidential.