Alaris Infusion Pumps are designed to deliver fluids to the body in a controlled manner. In 2019, Becton Dickson announced separate recalls for Alaris Infusion Pump Modules, Model 8100, and Alaris Pump Model 8100 Infusion Sets suspected of injuring patients.
The Alaris Pump Module, Model 8100, is a component of the Alaris electronic infusion pump system. Hospitals and other healthcare facilities use the Alaris Infusion Pump Module to deliver medications, blood, or blood products into a patient’s body in a controlled manner. The Model 8100 is compatible with the Alaris 8000 and Alaris 8015 PCU Infusion Pump units, and is indicated for adult, pediatric, and neonatal patients.
The Alaris Model 8100 Infusion Sets are comprised of:
The Alaris Infusion Pump Module, Model 8100, received marketing clearance through the U.S. Food & Drug Administration’s (FDA) 510(k) program, as did the corresponding Alaris Infusion Sets. This fast-track process allows manufacturers to avoid the time and expense of human testing if they can show that a new product is “substantially equivalent” to a device that has already been cleared for sale through the FDA’s stringent pre-market approval process.
Becton Dickson initially recalled Alaris Infusion Pump Modules, Model 8100, in September 2017, warning that a defect with the pumps’ bezels might cause the devices to deliver more or less of the desired dose. However, the first Alaris Infusion Pump recall only included the following products if their bezels were manufactured in October and November 2011:
In April 2019, Becton Dickson expanded the Alaris Infusion Pump recall to include any of the above products with bezels manufactured between April 2011 and June 2017.
The following month, Becton Dickson recalled millions of Alaris Model 8100 Infusion Sets because of non-uniform thickness in the walls of the silicone tubes. This defect could cause tubal collapse or a failure to stop fluid administration as designated by the pump. Such an occurrence could actually lead to an overdose, placing the patient at risk for severe injury or even death.
The FDA has apparently received hundreds of MDR reports related to the Alaris Infusion Pump recalls, including reports of serious patient injuries. As a result, the agency designated both actions Class I Medical Device Recalls.
Class I is the FDA’s most serious recall category. This designation indicates that there is a reasonable probability that the recalled Alaris Infusion Pump Module or recalled Alaris Infusion Sets will cause serious adverse health consequences or death.
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