Sunday, April 14, 2024

Infutronix Halts Distribution of Infusion Pumps in the US Following Surge in Complaints

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Infutronix, a medical device manufacturer, has initiated a recall of its Nimbus Infusion Pump Systems from the market in response to a significant number of complaints reported to the Food and Drug Administration (FDA). According to the FDA’s database, nearly 3,700 complaints have been lodged against these infusion pumps. This Class I recall, the most serious type of recall issued by the FDA, encompasses over 52,000 medical devices distributed throughout the United States.

The decision to recall the Nimbus Infusion Pump Systems was prompted by the identification of six distinct issues that can potentially lead to pump malfunctions. These issues, as outlined by Infutronix, include concerns related to pump shutdowns, infusion suspensions, drug product leaks, and incorrect medication dosages. Given the severity and potential risks associated with these malfunctions, Infutronix has opted to discontinue support for these devices effective June 20.

The recall underscores Infutronix’s commitment to prioritizing patient safety and ensuring the integrity and reliability of its medical devices. By taking proactive measures to address reported complaints and potential issues, Infutronix aims to mitigate any potential harm or adverse events that may result from the use of the Nimbus Infusion Pump Systems.

Infutronix Commits to Comprehensive Redesign of Recalled Infusion Pumps for Enhanced Safety and Performance

In addition to halting support for the affected devices, Infutronix is likely to implement corrective actions aimed at resolving the identified issues and preventing similar incidents in the future. These actions may include redesigning the infusion pumps to improve their mechanical, electronic, and software components, as well as enhancing aspects of the administration set to ensure optimal performance and safety.

Overall, the recall serves as a testament to Infutronix’s commitment to quality assurance and regulatory compliance. By promptly addressing reported complaints and taking decisive action to remove potentially defective products from the market, Infutronix demonstrates its dedication to maintaining the highest standards of product safety and efficacy in the healthcare industry.

Recognizing the need for substantial product enhancements, Infutronix determined that a redesign is necessary, encompassing mechanical, electronic, software, and housing improvements, as well as enhancements to the administration set. Given the extensive modifications required and the necessity for thorough design, verification, and validation processes, Infutronix may need to submit a new premarket notification for FDA clearance.

Infusion Pump

Infutronix Announces Nimbus Infusion Pump Withdrawal and Redesign for Enhanced Patient Safety and Device Reliability

As a result of the identified issues and the need for redesign, Infutronix has commenced the process of withdrawing the existing Nimbus infusion pump systems from the market. Simultaneously, the company is actively engaged in the redesign and regulatory clearance process for an updated version of the pump. In light of these developments, Infutronix has issued guidance to healthcare providers, urging them to promptly explore alternative methods for drug product infusion.

Recognizing the importance of ensuring uninterrupted patient care, Infutronix has established a streamlined return process for the recalled Nimbus devices. This initiative aims to facilitate the efficient and safe retrieval of the affected pumps from healthcare facilities. Throughout the removal period, healthcare providers are permitted to continue utilizing the Nimbus infusion pumps. However, users are advised to exercise caution and remain vigilant for any potential indicators of pump malfunction.

Healthcare professionals and users of the Nimbus infusion pumps are encouraged to remain alert for signs such as audible alarms, screen flickering, or evidence of fluid leakage, which may signify underlying issues with the device. By maintaining heightened awareness and promptly addressing any observed abnormalities, healthcare providers can help mitigate the risk of adverse events and ensure the continued safety and well-being of their patients.

Infutronix remains committed to prioritizing patient safety and upholding the highest standards of quality and reliability in its medical devices. The company’s proactive measures to address the identified issues underscore its unwavering dedication to maintaining the integrity and efficacy of its product offerings. Through collaboration with regulatory authorities and healthcare stakeholders, Infutronix is working diligently to implement necessary improvements and enhance the overall safety profile of the Nimbus infusion pump systems.

 

Resource: Mtech Dive, April 02, 2024

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