CareFusion (San Diego, CA) has faced several regulatory issues over the past year. In a continuance of its bad luck, the company is now reporting an issue with the PC unit of its Alaris infusion pump. The FDA issued Class I recall status for the infusion pump.
CareFusion first recalled the Alaris 8015 in March of this year. The medical device manufacturer warned that a communication glitch between the device’s attachment and its CPU could cause the keypad to become unresponsive. When the keypad loses its responsiveness, programmed infusions will continue. However, restarting the device could put patients at a high risk of serious injury or death.
The company is not requiring customers to returned the affected devices. Instead, representatives for CareFusion are offering software updates that resolve the issue.
The Alaris 8015 first showed problems in August of last year. At that time, CareFusion warned that the device’s power supply could malfunction under some conditions. This could potentially interrupt infusion, leading to FDA Class I recall status for the device. In addition, the company also received Class I status for its Alaris 8100 in August. Under some conditions, the protective keypad that covers the pump’s door could come loose. This could expose the keypad to liquids.
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