FDA Issues Baxter Infusion Pump Recall Requirements

The FDA has laid out requirements for the recall of Colleague Volumetric Infusion pumps by Baxter Healthcare Corp., instructing the company on how to refund or provide replacements for about 200,000 potentially dangerous infusion pumps. 

The FDA announced the infusion pump recall requirements on Tuesday, a little more than two months after it announced that Baxter would be forced to take its Colleague pump off of the market. Problems with Baxter Colleague infusion pumps have been linked to more than 500 deaths and 56,000 reports of adverse events.

The electronic infusion pumps are used to deliver medications or other fluids in controlled amounts to patients through epidural, intra-arterial (IA), intravenous (IV), and other methods of administration. The sophisticated devices monitor several sensors, medical-control software and electronics during therapy and automatically sound an alarm and shut down in a potentially harmful situation.

The recall requirements issued this week indicate that Baxter must provide a transition guide to help customers deal with the effects of the recall. The guide will include recommendations on how to minimize treatment disruptions and patient risks, a list of FDA-approved alternative pumps, and information on obtaining refunds or replacements and lease termination programs.

The FDA has identified serious flaws with the Colleague pumps since 1999, and there have been a number of Class 1 Baxter infusion pump recalls issued regarding problems with data errors, batteries, and power problems. A Class 1 recall is the most serious category of medical device recall, and is only issued when there is a high probability of severe injury or death to users. In 2006, the FDA obtained a court order halting the production of the infusion pumps until Baxter addressed some of the problems. So far, the company has failed to do so to FDA’s satisfaction.

The FDA ordered the company to conduct the recall after Baxter proposed a plan that would not have addressed serious issues with the pump until 2013. The FDA called the plan “unacceptable” as it left potentially dangerous infusion pumps on the market for another three years. The 2006 consent decree gave the FDA the power to take whatever action it felt appropriate to protect the public from the pumps, leading to this week’s recall.

The requirements will mean that Baxter will have to provide replacement parts and batteries for the pumps for up to 24 months, until the transition to other pumps has been completed. The recall, replacements and refunds are expected to be completed by July 14, 2012.

The FDA launched a new infusion pump safety initiative in April. The new initiative requires manufacturers to undergo more risk assessments before gaining approval for new or modified devices, and they will be expected to submit additional design and engineering information for premarket approval.

The new guidance comes following an FDA advisory panel meeting in March, which was called by regulatory agency due to a disturbing trend in the quality of infusion pumps. According to FDA, there have been 56,000 adverse event reports from people reporting problems with infusion sets in the last five years. In addition, there were 87 infusion pump recalls announced between 2005 and 2009.

Last summer, a Medtronic Paradigm insulin pump Quick Set Infusion Set recall was issued after the company determined that about 60,000 infusion sets used with the pumps were defective and could give too much insulin to users due to an air pressure problem.