Baxter Healthcare announced Tuesday that it plans to voluntarily withdraw its 6060 Multi-Therapy Infusion Pump from the market over the next 12 months.
This pump delivers intravenous medications to patients who are primarily in alternate care settings or at home. There are approximately 34,000 pumps currently in use worldwide, including 30,000 in the United States.
In a letter to customers, Baxter stated that it had received reports of one death and two serious injuries due to malfunctions in the pump. The pump may deliver drugs when they are not requested or fail to deliver drugs when they are requested. These product failures can result in an unsafe situation for patients.
Baxter will be working with customers to conduct a controlled removal of all 6060 Infusion pumps from the market. During the transition period, Baxter will continue to provide service and sets for the 6060 pump. Baxter has entered into an agreement with Smiths Medical to provide alternative infusion pumps and products during the transition.
This is not the first time that Baxter has had a problem with its medical pumps. In September, there was a recall of the company’s Colleague Infusion pumps due to battery problems, and in October, the U.S. Food and Drug Administration (FDA) seized 6,000 pumps from Baxter’s manufacturing facilities in Illinois because the firm had continually failed to follow medical device manufacturing requirements.