By Rajani Kumar Sindavalam

Infusion pumps are essential instruments in contemporary healthcare, facilitating the precise delivery of fluids, medications, and occasionally nutrients. Ranging from simple syringe pumps to advanced smart pumps equipped with integrated drug libraries and connectivity options, these devices are crucial for patient care in various clinical environments.

Nevertheless, the growing complexity of infusion pumps, spurred by the need for improved functionality and seamless integration within the healthcare system, presents considerable challenges. Risks to patient safety arise from medication errors, usability concerns, cybersecurity threats, and interoperability issues, which impede the complete achievement of their clinical capabilities.

Systems engineering—an interdisciplinary domain dedicated to the design, development, and management of intricate systems throughout their lifecycles—provides a systematic framework to tackle these challenges. By embracing a comprehensive viewpoint that considers all stakeholders, system elements, and their interrelations, the medical technology sector can facilitate the creation of safer, more user-centric, and genuinely intelligent infusion pumps.

Challenges in Infusion Pump Development

Developing infusion pumps is complex and necessitates a robust systems engineering methodology. These challenges include both technical and clinical dimensions, each with direct implications for patient safety and regulatory compliance:

• Safety-Critical Nature: Infusion pumps directly impact patient health. A malfunction—such as the over- or under-administration of essential medications—can have serious or life-threatening consequences. Safety must remain the top priority throughout every stage of development.
• Stringent Regulatory Requirements: Medical devices, including infusion pumps, are subject to rigorous oversight from regulatory bodies such as the US Food and Drug Administration and European Medicines Agency. Compliance demands extensive documentation, testing, and validation—core elements of systems engineering that ensure quality and accountability.
• Human Factors and Usability: These devices are often used in fast-paced clinical environments. Poorly designed interfaces, unclear alarms, or complex workflows increase the likelihood of error. Integrating human factors engineering into the design process helps ensure devices are intuitive and safe to use.
• Software Complexity: Modern pumps rely heavily on embedded software for drug delivery, alarms, and connectivity. As functionality expands, so does the potential for defects. Addressing this complexity requires disciplined software development practices.
• Interoperability and Data Integration: Infusion pumps must integrate with systems like EHRs and pharmacy platforms. Achieving seamless, secure interoperability requires careful design and validation to maintain data integrity.
• Cybersecurity Threats: Network-connected pumps are vulnerable to cyber threats that could impact functionality or expose patient data. Embedding robust security protocols from the start is essential.
• Lifecycle Management: Systems engineering must span the entire product lifecycle, including manufacturing, maintenance, and disposal. Ongoing oversight ensures continued performance and safety.

Putting Systems Engineering to Work

A systematic application of systems engineering principles helps navigate these challenges. The process begins with stakeholder analysis and requirements elicitation—identifying the needs of patients, clinicians, pharmacists, engineers, and regulators. For example, insights from ICU nurses can inform interface design and alarm functionality.

Functional analysis and system architecture design follow, breaking the pump into components such as fluid delivery, occlusion detection, user interface, and data transmission. A well-structured architecture promotes modularity, testability, and long-term maintainability.

Risk management is central. Structured tools like Failure Modes and Effects Analysis and hazard analysis help identify and mitigate risks early. For instance, analyzing potential failure points in the pump mechanism can support the development of more responsive occlusion detection.

Human factors engineering and usability testing ensure that the pump is intuitive and minimizes user error. Simulated clinical testing with representative users helps refine visual and auditory alarms and workflow steps.

Given the pump’s software dependence, software systems engineering is vital. This includes managing requirements, developing architecture, performing rigorous testing, and ensuring cybersecurity. Following standards like IEC 62304 and using secure coding practices reduces risk.

Verification and validation—from unit tests to system-level evaluations and clinical trials—confirm the device meets specifications and performs safely.

Configuration management and traceability maintain oversight of documentation, components, and changes across the lifecycle. Traceability matrices linking requirements to test cases and risk controls reinforce a disciplined development process.

Finally, post-market surveillance ensures continued device safety. Monitoring field performance, collecting feedback, and managing recalls allow for continuous improvement based on real-world data.

Powering the Next Generation of Smart Infusion Pumps

Emerging technologies such as artificial intelligence (AI), machine learning (ML), and improved connectivity are propelling the development of smart infusion pumps. Systems engineering ensures these innovations are integrated safely and effectively.

Predictive analytics powered by AI/ML can identify potential issues like occlusions or low medication levels before they occur. Systems engineering defines the requirements for these algorithms, supporting accuracy and safety.

Connectivity and interoperability are essential. Pumps must reliably exchange data with EHRs, pharmacy systems, and other devices. Engineering principles guide the development of secure interfaces and resilient communication protocols.

Looking ahead, real-time patient data may be used to adjust infusion rates dynamically. Developing these adaptive control features requires validated algorithms and integration into reliable feedback systems.

What’s Next—and What’s Needed

To support the continued evolution of infusion pumps, manufacturers should embrace key best practices. These include early and ongoing stakeholder engagement to ensure development is aligned with real-world clinical needs. Involving users from the outset helps avoid costly redesigns later.

Additionally, comprehensive risk management should be embedded across all phases of development as proactively addressing safety risks leads to safer, more robust devices.

Human-centered design, including attention to usability and clinical workflows, helps ensure safe and intuitive operation in demanding settings, while interoperability remains essential. Standardized communication protocols simplify integration with other health IT systems.

Software and cybersecurity practices must evolve with the technology. Adhering to development standards and adopting secure design principles will reduce vulnerabilities.

Additionally, post-market surveillance using real-world data helps identify issues and guide iterative improvements, and ethical considerations around AI and ML should be addressed early. Transparency, accountability, and bias mitigation are critical for responsible integration.

Finally, industry-wide collaboration can accelerate progress. Sharing best practices, tools, and lessons learned contributes to safer, smarter infusion technology.

The Path Forward

Advancing smart infusion pumps requires a comprehensive approach grounded in systems thinking. By applying engineering principles across the entire lifecycle—from early design to post-market surveillance—developers can build safer, more reliable devices.

As the medtech industry continues to innovate, systems engineering provides the foundation for addressing complexity and unlocking the full potential of infusion pump technology to improve patient outcomes. 

About the Author: Rajani Kumar Sindavalam is a senior technical manager and medical device leader at HCLTech. He has more than 19 years of experience supporting the development of medical technologies, including infusion pumps, bedside monitors, dialysis cyclers, and nerve stimulators.

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The US Food and Drug Administration (FDA) has granted 510(k) clearance for Iradimed Corporation’s MRidium 3870 infusion pump system, the company’s next-generation magnetic resonance imaging (MRI)-compatible intravenous infusion pump.

Designed for use in MRI environments, the MRidium 3870 builds on Iradimed’s earlier systems, which the company says remain the only non-magnetic infusion pumps cleared for use during MRI procedures.

“We are thrilled to receive FDA 510(k) clearance for the MRidium 3870, a milestone that underscores our commitment to advancing MRI-compatible medical technology,” says Roger Susi, president and CEO of Iradimed Corporation, in a release. “This long-awaited clearance reflects our productive collaboration with the FDA to meet evolving and stringent regulatory requirements. The MRidium 3870 empowers clinicians to deliver critical IV fluids and medications safely and predictably in MRI environments, improving patient outcomes and operational efficiency.”

Iradimed expects to begin rolling out the MRidium 3870 at select healthcare facilities in the fourth quarter of 2025, with broader commercial distribution to follow in 2026.

The company, which received FDA clearance for its first-generation infusion pump in 2005, also manufactures non-magnetic patient monitoring systems designed for use in MRI suites. According to Iradimed, the new device expands its offerings for hospitals seeking MRI-compatible solutions in anesthesiology and critical care.

Photo caption: MRidium 3870 infusion pump system

Photo credit: Iradimed Corporation

Further Reading:

By Alyx Arnett

The US Food and Drug Administration (FDA) has issued a warning letter to ICU Medical, citing regulatory violations related to unapproved modifications to two of its infusion pumps: the Medfusion Model 4000 Syringe Infusion Pump and the CADD Solis VIP Ambulatory Infusion Pump.

Following an inspection conducted between July 23 and Aug 9, 2024, at a Minneapolis facility acquired by ICU Medical through its 2022 purchase of Smiths Medical, the FDA found that the company had made significant changes to the devices without submitting the required premarket notifications. According to the agency, the modifications—including software updates intended to address safety concerns—could significantly affect the pumps’ safety and effectiveness.

Both devices were previously cleared by the FDA under earlier 510(k) submissions, in 2011 for the Medfusion Model 4000 and in 2013 for the CADD Solis VIP. However, the FDA said ICU Medical failed to notify the agency of later changes that potentially impact the pumps’ risk profiles, including risks of under- or over-infusion, therapy delays, and false alarms that could lead to serious patient harm such as overdose or cardiorespiratory compromise.

The FDA also noted that some of the changes were part of a Class I recall response addressing issues with fluid delivery, therapy interruptions, and false alarms. Despite identifying new or significantly modified risks during its internal assessments—risks that, according to company procedures, would require a new 510(k)—ICU Medical had not submitted updated applications to the agency.

“Adding a statement to your labeling that the device software has not undergone FDA review is not sufficient,” the agency wrote in the warning letter dated April 4, 2025.

ICU Medical was given 15 business days to respond with specific steps it has taken to address the violations and prevent similar issues from recurring. Failure to do so could result in regulatory actions such as seizure, injunction, or civil money penalties, the FDA said.

In response to a request for comment, ICU Medical told 24×7 that patient safety and regulatory compliance remain its top priorities. The company noted it has invested hundreds of millions of dollars to improve quality and service since acquiring Smiths Medical and that new 510(k) submissions for the CADD and Medfusion pumps have been in progress, with plans to submit them within the next 90 days.

ICU Medical also highlighted that an August 2024 FDA inspection tied to a prior 2021 warning letter for Smiths Medical was completed with zero observations and pointed to recent 510(k) clearances as evidence of its strong standing and communication with the agency. Commercial operations remain business as usual, the company says.

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Related Read:

ICU Medical Inc announced 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for the Plum Solo precision IV pump, a single-channel complement to the dual-channel Plum Duo. 

ICU Medical also received 510(k) clearance for updated versions of the Plum Duo precision IV pump and LifeShield infusion safety software, completing the initial launch of the ICU Medical IV Performance Platform. With these FDA clearances, ICU Medical is introducing its new category of precision IV pumps and expanding the ICU Medical IV Performance Platform.

Unlike traditional pumps that rely on specific setups and conditions for accurate delivery, precision IV pumps are designed to address delivery variability while supporting the increasing need for accurate data in modern patient care. Built on cassette technology in the Best in KLAS award-winning Plum 360, the Plum Solo and Plum Duo precision IV pumps deliver ±3% accuracy in real-world conditions and eliminate the infusion inconsistencies found in traditional pumps.

“Precision IV pumps represent a critical step forward for infusion therapy,” says Chad Jansen, corporate vice president and general manager of ICU Medical Infusion Systems, in a release. “With the Plum Solo and Plum Duo, we’re introducing more than just a new device category—we’re setting a new standard. Healthcare teams can now trust not only the delivery of their medications but also the infusion data that supports their decisions, knowing it reflects what patients actually receive.”

The Plum Solo expands the capabilities of the IV Performance Platform by offering a single-channel pump designed to work alongside the dual-channel Plum Duo—recently recognized in a KLAS Emerging Insights Report with emerging data showing an A+ rating for new technology, likely to recommend, and money’s worth.

Expanding Infusion Platform

Together, Plum Solo and Plum Duo provide healthcare systems with the flexibility to choose the right configuration for their infusion needs. Both devices are compatible with whole blood and blood products and deliver consistent ±3% accuracy while eliminating variability from external factors such as infusion setup, temperature, or hospital elevation. 

“We are proud of this milestone, but this is just the next step in creating the most comprehensive, precise, and technologically advanced infusion platform,” Jansen says in a release. “This milestone delivers on our promised roadmap with five products receiving FDA 510(k) clearance in the past 18 months. We look forward to bringing our next-generation Medfusion syringe pump and CADD pain and ambulatory pump products to the LifeShield platform. This is the future of infusion therapy, and we’re proud to be leading the way.”

Photo caption: With these FDA clearances, ICU Medical is introducing its new category of precision IV pumps and expanding the ICU Medical IV Performance Platform.

Photo credit: ICU Medical

Key Takeaways

• New Device Introduction: Inspira Technologies unveiled the INSPIRA Cardi-ART, a portable device for oxygenating the brain during cardiac arrest.
• Broad Application: The device targets both in-hospital and out-of-hospital cardiac arrests, aiming to enhance survival rates with rapid oxygenation support.

Inspira Technologies, provider of life-support technology, introduced the INSPIRA Cardi-ART, a portable modular device, currently in development, to provide oxygen to the brain during cardiac arrest.

The device is expected to expand the next-generation INSPIRA ART platform to a wider range of applications.

Design and Application

The INSPIRA Cardi-ART is being designed to support vital organ oxygenation during cardiac arrest to treat patients both in and outside of hospitals. The company plans the regulatory submission of the device to the U.S. Food and Drug Administration for as early as 2026, pending the final regulatory pathway.

Today, nearly 70% of cardiac arrests occur outside of the hospital, of which there is a mortality rate of approximately 90%. The device aims to improve survival rates of cardiac arrest patients with the Company’s core blood oxygenation and monitoring technologies, targeting new applications in the global cardiac arrest market.

Features of INSPIRA Cardi-ART

The INSPIRA Cardi-ART portable modular unit is being designed for fast emergency response during CPR (cardiopulmonary resuscitations) in and outside of hospitals, allowing for rapid cannulation and the delivery of oxygenated blood throughout the body to reduce damage to the heart and brain during cardiac arrest. The device is being designed to monitor key vital parameters using the HYLA blood sensor technology.

Functionality

The INSPIRA Cardi-ART is being designed to provide quick hemodynamic support in the case of cardiac failure as it drains blood, exchanges gases, and then returns the blood to the arterial system to maintain systemic perfusion. The technique has been used in other procedures that have been recommended in medical guidelines as set out by the American Heart Association (AHA).

“The INSPIRA Cardi-ART may become the difference between life and death during a cardiac arrest event, where the medical team sometimes has only minutes to provide critical life-saving care,” said Dr. Dekel Stavi, Inspira Technologies’ medical director.

Adding LVP modality to the Novum IQ Infusion Platform—which includes Baxter’s syringe infusion pump (SYR) with Dose IQ Safety Software, powered by the IQ Enterprise Connectivity Suite—enables clinicians to utilize a single, integrated system across a variety of patient care settings.

“The Novum IQ platform represents a meaningful shift in how connected and intelligent infusion therapy can impact the way clinicians provide care,” said Heather Knight, executive vice president and group president, Medical Products and Therapies at Baxter. “Offering Novum IQ large volume and syringe infusion pumps unlocks the potential of advanced, intuitive technologies that customers seek to meet their needs.”

Features of the Platform

The Novum IQ Infusion Platform integrates user experience across its LVP and SYR pumps and helps to reduce the burden of non-critical tasks so that nurses, pharmacists and other clinicians can spend more time focused on patient care. Highlights of the platform include:

• Novum IQ LVP and SYR infusion pumps, which share a common user interface designed to accomplish association between a patient, medication and pump through a digital on-screen barcode. The pumps’ integrated experience also streamlines the training that clinicians need and helps reduce the cognitive burden associated with understanding how to properly operate multiple, disparate pump platforms.
• Dose IQ Safety Software, which features a web-based, customizable drug library and dose error reduction system. Dose IQ supports clinicians and hospitals by helping ensure pumps are up to date with the latest, facility-specific drug and dosage parameters and information through centralized access to current drug library files. In addition, Dose IQ includes exclusive titration error prevention technology designed to provide additional safety measures.
• IQ Enterprise Connectivity Suite, a scalable server, integration engine and software application platform, designed to simplify infusion system connectivity for the Novum IQ Infusion Platform.
• Cybersecurity rigor, with Dose IQ Safety Software and IQ Enterprise Connectivity Suite both certified to the UL 2900 Series of Standards.

Based on clinical setting and patient need, hospitals may need and benefit from having access to both LVP and SYR pumps. Baxter’s Novum IQ LVP supports the administration of high-volume infusions at faster rates, while Novum IQ SYR supports the delivery of small, precise amounts of fluid at lower rates, often in pediatric, neonatal or anesthesia care settings.

The Novum IQ LVP and Novum IQ SYR are available to order in the U.S. Baxter expects to expand the platform in the future through continued product development and additional regulatory submissions.

The recall was due to a high number (3,698) of customer complaints related to the Nimbus Infusion Pump systems dating from May 2019 to August 2023. An evaluation of complaint data identified several potential product issues:

• Battery Power may potentially affect the performance of the pump by causing an immediate power off event.
• Upstream Occlusion, as noted by the upstream occlusion alarm, occurs when there is a block in flow of the proximal end of the administration set.
• System Errors, as noted by the System Error alarm which causes the pump to suspend the infusion.
• Drug product egress from certain administration set bonding points, which may potentially result in drug product leaking from the device.
• Flow Rate (high or low) which may potentially lead to the pump infusing an inaccurate delivery of the drug.
• Pump Housing design which may potentially result in damage over time to certain areas of the housing responsible for administration set engagement, leading to false occlusions and flow rate inaccuracies.

Nimbus Infusion Pump Corrective Actions

InfuTronix determined that the best way to address the identified product issues and potential outcomes is a redesign of the Nimbus Infusion Pump system.

The redesign will allow InfuTronix to improve several aspects of the product including mechanics, electronics, software, and housing design as well as aspects of the administration set. Given the number of anticipated design improvements and the extensive requirement for design, verification, and validation, InfuTronix believes a new premarket notification(s) and clearance from FDA may be required.

As a result, InfuTronix is seeking to remove the system from the market while these improvements and design changes are being made and a new clearance is obtained.

An independent evaluation has determined that the common device failure modes pose a low risk to users.

Recommendations for Continued Usage

Users may continue to use the Nimbus Infusion Pump system and associated infusion sets during this removal process. Users should be aware of the signs indicating a potential issue with the pump (How to recognize that a device may fail):

• Battery – The infusion pump will brown out (fail-safe). The user will see that the pump has shut off. Additionally, the LED screen may flicker prior to failure, indicating a potential battery issue.
• Upstream Occlusion – Auditory and visual occlusion alarm alerts the user of the occlusion.
• System Error – Auditory and visual system error alarm will alert the user.
• Drug Product Egress – The user may notice leaking drug from the pump pouch or infusion set or feel wetness from the drug product.
• Flow Rate (high/low) – Auditory and visual occlusion alarm for low flow will alert the user of occlusion. The user will notice residual volume remaining at the end of therapy. High flow rate may be associated with shortened infusion times.
• Pump Housing Damage – The user may notice broken latches, hinges, or cracks in the housing and/or user may notice that the device is difficult to assemble prior to use.

Infutronix has already notified customers with a letter that details the products impacted, reason for the voluntary removal, risk to health assessment, how to recognize the device may fail and actions to be taken by the customer/user.

The flaw is causing the pins to malfunction, striking the side of a sensor instead of moving correctly. This malfunction triggers an alarm within the system, halting ongoing infusions and rendering the pump inoperable. The issue may also be detected during the LVP setup, causing potential delays in initiating medical treatment.

The use of the affected product poses serious risks, including underdosing, therapy interruptions, or delays that could result in significant harm or even death. Despite the severity of the flaw, no injuries or deaths have been reported at this time. The U.S. Food and Drug Administration (FDA) has classified this recall as Class I, indicating it as the most serious type of recall due to the potential for severe injuries or fatalities.

On November 28, 2023, Fresenius Kabi took swift action by sending an Urgent Medical Device Recall notice to all affected customers. The notice outlined crucial steps for customers to follow, including reviewing and posting lists of affected serial numbers, sharing required actions and affected serial numbers at nursing stations, and enhancing clinical monitoring for life-sustaining medications delivered via the Ivenix LVP.

Customers were advised to use alternative pumps if the LVP displayed a Pump Problem alarm during setup, remove affected LVPs showing such alarms during use, and inform potential users about the recall letter. Fresenius Kabi committed to reaching out to customers through service representatives to develop plans for addressing affected LVPs starting in January 2024.

The Ivenix Large Volume Pump is a vital component of the Ivenix Infusion System, representing one of three primary elements. This pump utilizes air pressure to precisely control fluid flow to patients. The Ivenix Infusion System is deployed in hospitals and outpatient centers to administer fluids to patients through various routes such as IVs, arteries, the spine, or under the skin. Targeted at adults, pediatrics, and newborns, the Ivenix Large Volume Pump is compatible only with specific sterile, single-use, disposable administration sets. The recall serves as a crucial measure to safeguard patient health and well-being.

The Caresite Micro Device is the only needleless connector not made with Bisphenol A (BPA), a harmful chemical known to cause multi-organ toxicity. Made with a drug-resistant material, the Caresite Micro Device can help reduce the risk of infections and drug exposure resulting from stress cracks associated with material and drug incompatibility.

Hospital-acquired bloodstream infections (HA-BSIs), which are often associated with catheter insertions, remain a major cause of morbidity and mortality. The Caresite Micro Device features a smooth, flat surface that allows proper disinfection, and a straight fluid path design that helps complete flushing of blood and medications with a small flush volume, helping to reduce the risk of HA-BSI.

“We are excited to introduce the Caresite Micro Luer Access Device. Helping to reduce HA-BSIs and accidental drug exposure supports our commitment to the safety of the patients and providers we serve,” says Angela Karpf, MD, corporate vice president, medical affairs.

Infusion pumps are used throughout hospitals and other sites of care to deliver medications and fluids to patients. The Fresenius Kabi Ivenix Infusion System smart pump features a smartphone-like touchscreen and patented pumping mechanism. Ivenix pumps also interface with hospital information systems and electronic medical records.

“Technology is transforming patient care, and at Fresenius Kabi our focus is on scaling advanced technologies and essential medicines so they can benefit more patients in more places,” said Dr Christian Hauer, president, Fresenius Kabi MedTech. “We are honored to collaborate with – and to serve – the care teams at Mayo.”

This is the largest contract for Ivenix pumps Fresenius Kabi has signed to date.

“For our customers, patients and partners, Fresenius Kabi is committed to enhancing the intelligence and reliability of infusion systems,” said Pete Allen, senior vice president, U.S. Infusion Therapy and Nutrition. “This agreement represents the culmination of a tremendous amount of work by our engineering and commercialization teams, and we are committed to delivering an outstanding experience for Mayo and its care teams.”