FDA infusion pump recall points to greater product concern

infusion pump recallThe recall by the U.S. Food and Drug Administration of one medical company's entire line of infusion pumps -- widely used to administer fluids to the human body -- has called attention to persistent safety problems across the industry.

The federal agency ordered Baxter International, one of the leading manufacturers, to "recall and destroy" all its Colleague brand pumps in the U.S., about 200,000. The recall follows repeated FDA attempts to work with Baxter to resolve serious safety problems.

Infusion pumps deliver fluids, including nutrients and medications such as antibiotics, pain relievers and chemotherapy drugs, in a controlled manner. They are widely used in hospitals, clinical settings, and by people, because of their accuracy.
The FDA identified numerous malfunctions with Baxter pumps: software problems, alarm errors, inadvertent power off, sparks and shocks, and faulty interface design. A problem known as "key bounce" -- the pump interpreting a single keystroke as multiple ones -- is of particular concern.

"This is important to us, because 'key bounce' is an issue that has been well-studied before -- it exists in everything from microwaves to cell phones. So you would think that a minimum amount of attention should be paid when it concerns critical devices," said Dick Thompson, a spokesman for the FDA, in an interview.

An example of such consequence would be a patient or a nurse programming an infusion of 10 mL per hour, but the device registering it as one of 100 mL per hour.

A spokeswoman for Baxter, Erin Gardiner, told Consumer Ally the company had been planning to retire the Colleague pumps, which were introduced in 1997. Gardiner said although the company has been collaborating with federal health regulators to fix concrete issues throughout the years, it hasn't been able to keep up with new and evolving requirements in the timeframe the FDA had set.

Infusion pumps, not limited to the Baxter Colleague brand, have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events related to the use of infusion pumps, including more than 500 deaths. Between 2005 and 2009, the agency has conducted 87 infusion pump recalls to address specific safety concerns.
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