Alaris Pump Recall Issued Over Unresponsive Keys Following Dozens of Complaints
Nearly 150,000 BD Alaris infusion pumps have been recalled following reports of problems where the keypad may not work properly, which could delay critical drug infusions and result in serious injury or death.
The FDA announced the BD Alaris Infusion Pump Recall on April 16, following nearly 80 complaints. However, there have not yet been any reports of injuries or deaths associated with the problem.
The BD Alaris Pump Module System is an infusion pump and vital signs monitoring system. It includes a PC Unit, the Guardrails Suite MX, and up to four removable infusion or monitoring modules. The pump system is used to deliver medications, blood, and blood products into a patient’s body in a controlled manner. The BD Alaris Pump Module System is commonly used in hospitals and other healthcare facilities.
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According to the recall warning, the recalled infusion pumps may experience stuck or unresponsive keys, which could lead to a pump failure in delivering appropriate medications or blood for patients.
The malfunction occurs when the keypad lifts during fluid delivery. When the keypad lifts it can cause the keys to become unresponsive or stuck. Problems with the keys can lead to a delay of infusion for medication or blood. It can also lead to a complete interruption, preventing the needed medication or blood from being received by the patient. It can also prevent a doctor or healthcare provider from changing needed fluids or medications on the device in a timely manner, further delaying treatment.
Those at most risk of side effects from the pump malfunction are high-risk patient populations who are receiving life-sustaining infusions. These patients may experience delays or interruption of infusions which can cause serious injury or death.
This has led to the FDA designating the action as a Class I medical device recall, which is the most serious category, suggesting continued use of the product may cause serious injuries or death to the user.
The recall involves the BD Alaris Infusion Pump Module, model number 8100. It also affects parts 49000239; 49000346; 49000438; and 49000439, which were manufactured January 15, 2019, to December 5, 2019, and distributed January 23, 2019, to December 5, 2019.
A total of 145,492 devices have been recalled since the manufacturer, Carefusion 303, Inc., first told customers about the problem on March 3, 2021.
The FDA recommends removing the pump from service and sending the device to Biomedical Engineering staff if the Pump Module keypad shows signs of lifting, becomes unresponsive or stuck.
The agency also recommends healthcare providers continue an infusion of critical medications that have already begun and wait to remove the pump from service until it is safe to replace the PC Unit. In an urgent situation, healthcare providers should close the roller clamp on the IV administration set to stop an infusion.
Questions about the BD Alaris Pump Module System recall should be directed to CareFusion 303 at 888-562-6018. Side effects related to use of the pump should be reported the FDA’s MedWatch Adverse Event Reporting Program.
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