August 25, 2012 — CareFusion and the U.S. Food and Drug Administration (FDA) have announced a voluntary Class 1 recall of a fluid infusion pump, the second Class 1 recall of a CareFusion infusion pump this month. The newest recall involves the CareFusion 303, Alaris Pump Module, Model 8100. The problem is that the covering to the keypad can loosen or detach, which might allow fluid to leak inside the device. The pump can malfunction, causing the alarm to go off. It is possible that the malfunctioning device could cause severe injury or death to a patient.
The CareFusion infusion pump is a type of medical device used to pump fluids into a patient mechanically. Fluids may include blood, drugs, or blood products, and they can be delivered to a patient in several ways — including intravenous, intra-arterial, epidural, and more. The products being recalled were manufactured from October 2011 until February 2012.
CareFusion addressed the issue by sending a notification to their customers and distributors in July. The company is advising people who purchased the infusion pump to visually inspect the device for signs that the keypad covering has come loose or is peeling away. Defects with the keypad covering might allow fluid to enter the device.
CareFusion and the FDA issued another Class 1 recall of another infusion pump earlier this month. That product, the Alaris PC unit Model 8015, was recalled because there were potential problems with the product’s power supply board.
A Class 1 recall is the most serious, urgent type of recall that the FDA can initiate. These recalls are reserved for scenarios where a defective medical device, product, or drug is at risk of causing severe injury or death to a person.
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