BD Alaris Infusion Pump Module Model 8100 Recalled Again and Labeled Class I Event by FDA
WASHINGTON, DC – The US Food and Drug Administration announced that BD / CareFusion 303 Inc is recalling 145,000 of its Becton Dickinson Alaris pumps. The recall is classified as a Class I recall because the pump’s defect may cause serious injury or death. The defect can cause the buttons to become stuck or unresponsive once pressed leading to delayed infusions, and “preventing clinicians from changing fluid and medication infusions used with the pump.”
CareFusion 303 Inc., a BD owned company, announced the recall for the BD Alaris Infusion Pump Module Model 8100 due to the danger of the “keypad lifting up as a result of fluid entry.”
According to the FDA’s recall announcement, there have been 79 complaints regarding the defect. The FDA stated that this recall is separate from the other Alaris Infusion Pump Module Model 8100 recall that was issued back in August 2020 for a related issue.
Technical issues associated with BD’s Alaris pump systems have resulted in nine Class I recalls since 2019. In the past year, there have been five recalls alone. The perpetual problems with BD’s Alaris pump system has caused the FDA to request BD to file a new 510(k) application for FDA review. The CEO, Tom Polen, stated that the company anticipates filing for the new 510(k) application in the second or third quarter of 2021.
The malfunctions that caused this most recall are linked to past issues with the same Alaris Infusion Pump Module Model 8100; however, the issues are separate from the August 2020 recall.
A BD spokesperson stated that the recalls are both involve the model’s keypad and its potential for fluid ingress causing a keypad function. BD also stated that this recall is for devices manufactured from January 23, 2019, until December 5, 2019. According to BD, any devices that were remediated during the August 2020 recall do not need to be replaced.
According to company warnings to purchasers of the he company’s Alaris Infusion Pump Module Model 8100, high-risk patients who are “receiving life-sustaining infusions are at the greatest risk of harm,” because a delay, interruption of an infusion could cause serious injury or death.
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