Ivenix Large Volume Pump Infusion System Software Failure Lawsuit Lawyers

FDA Announces Class I Recall of Ivenix Large Volume Pumps After Software Malfunctions Cause Serious Injuries

The U.S. Food and Drug Administration has issued its most serious recall designation, a Class I recall, for certain Ivenix Large Volume Pumps (LVPs) manufactured by Fresenius Kabi. A Class I recall is reserved for products that present a reasonable probability of causing serious injury or death. This designation reflects the gravity of the risks associated with the affected infusion systems.

Infusion pumps are critical medical devices used in hospitals and outpatient settings to deliver fluids, medications, blood products, and life-sustaining treatments. Patients receiving chemotherapy, antibiotics, pain medication, parenteral nutrition, blood transfusions, and other essential therapies often rely on these systems for precise and continuous administration.

When a device responsible for delivering life-sustaining treatment fails, even briefly, the consequences can be catastrophic. According to federal safety communications, two serious injuries have already been linked to the software anomalies in these pumps. In emergency care settings—where seconds matter—a sudden shutdown or interface failure can interrupt vital treatment at a critical moment.

For patients and families affected by this recall, the legal implications may be significant. Medical device manufacturers are required to design, test, and monitor products to ensure they are reasonably safe for their intended use. When preventable software defects result in harm, injured patients may have grounds to pursue compensation.

What Parker Waichman LLP Found

• The FDA classified the recall as Class I, its most serious designation.
• Software versions 5.10.1 and earlier can trigger sudden shutdowns or interface freezes.
• Two serious injuries have already been confirmed.
• Unexpected infusion interruption can cause life-threatening complications.
• Patients harmed before corrective updates may have grounds for a lawsuit.

What Devices Are Included in the Recall?

The recall involves:

• Product Name: Ivenix Large Volume Pump
• Defective Software Version:10.1 and earlier
• Product Code: LVP-SW-0005

These pumps are used in both hospital and outpatient clinical environments. Because they are internet-connected systems, they rely heavily on software performance to regulate infusion rates, monitor battery capacity, and provide alerts.

The recall requires facilities to update affected devices to software version 5.10.2. Until that corrective update is installed, the pumps may pose a serious threat to patient safety.

Hospitals and treatment centers are instructed to identify affected units immediately and implement corrective action. However, when a recall occurs after injuries have already been reported, it raises questions about how long the issue may have been present before corrective measures were initiated.

Software Malfunctions That Led to the Recall

Two primary software anomalies prompted the recall. Both involve failures that can interrupt infusion therapy in dangerous ways.

Inaccurate Battery Capacity Readings

One defect causes the pump to miscalculate or inaccurately display the remaining battery capacity when operating on battery power. In certain circumstances—particularly when the pump has been used extensively without connection to an external power source—the device may suddenly shut down without providing the usual warning alarm.

This creates several layers of risk:

• Sudden termination of medication delivery
• Interruption of blood transfusions
• Delayed treatment during critical care
• Lack of warning to clinical staff

Unexpected shutdowns during infusion therapy can have life-threatening consequences. Patients in intensive care, undergoing surgery, or receiving emergency treatment may rely on uninterrupted administration of fluids or medications. An unanticipated device failure can result in severe injury, complications, or death.

User Interface Lockout Due to Entry Error

The second defect involves a software glitch triggered when an infusion rate beginning with two leading zeros—such as “0010”—is entered. If the user presses “Back” or “OK” after entering this rate, the pump may enter what is known as a fail-stop state. In practical terms, the interface freezes and becomes unresponsive.

When the interface locks:

• Infusion may stop mid-treatment
• Staff must troubleshoot or reboot the device
• Time is lost while restoring functionality
• Patients may experience gaps in therapy

In emergency settings, even short delays can result in oxygen deprivation, blood loss complications, medication underdosing, or other serious outcomes.

Why a Class I Recall Matters

A Class I recall signals the highest level of concern. It means there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

In the context of infusion systems, reliability is non-negotiable. These devices are entrusted with delivering life-sustaining therapies. Software design must anticipate foreseeable use conditions, including battery operation and user input scenarios.

When a device’s programming allows foreseeable inputs to cause total system failure, it raises concerns regarding:

• Software validation and verification processes
• Risk analysis during product development
• Post-market surveillance
• Timeliness of corrective action

Patients injured as a result of such failures may pursue claims under product liability laws. These cases may involve allegations of defective design, failure to warn, or negligent manufacturing and testing.

Potential Injuries Linked to Infusion Pump Failures

The consequences of infusion pump malfunction depend on the type of therapy being administered at the time of shutdown or interface freeze. Injuries may include:

• Complications from interrupted blood transfusions
• Sepsis due to delayed antibiotic administration
• Cardiac complications from interrupted cardiac medications
• Severe dehydration or electrolyte imbalance
• Worsening of infection or disease progression
• Stroke or neurological damage due to treatment delay
• Organ failure

In some circumstances, injuries may not be immediately recognized. A delay in medication delivery can trigger cascading complications hours or days later.

If a patient experienced sudden deterioration during infusion therapy involving one of the recalled devices, it is critical to investigate whether a pump malfunction contributed to the harm.

Manufacturer Responsibilities and Legal Accountability

Medical device companies are legally obligated to ensure that products placed into the stream of commerce are reasonably safe when used as intended. This obligation includes:

• Adequate software testing
• Identifying foreseeable user inputs
• Stress-testing battery functionality
• Prompt reporting of known issues
• Issuing timely corrective actions

If software anomalies were known or discoverable prior to the reported injuries, liability exposure may increase. Product liability claims can seek compensation for:

• Medical expenses
• Future medical care
• Lost income
• Loss of earning capacity
• Pain and suffering
• Permanent disability

Hospitals and healthcare providers may also face scrutiny if warning signs were overlooked. However, the primary responsibility for a defective device typically rests with the manufacturer.

Lawsuit FAQs Ivenix Large Volume Pump Lawsuit FAQs

Can I file a lawsuit if I was injured before the software update was issued?
Yes. If the injury occurred while the defective software was in use, you may have a claim. The fact that a corrective update was later released does not eliminate liability for harm that occurred before the fix was implemented.

What must be proven in an infusion pump lawsuit?
Generally, a claim must show that the device was defective, that the defect existed when it left the manufacturer’s control, and that the defect directly caused injury. Medical records, device logs, and expert analysis often play an important role.

What if the hospital did not install the update promptly?
Liability depends on the circumstances. The manufacturer may still bear responsibility if the defect was present before the recall notice. In some cases, healthcare facilities may also be evaluated for their response time and compliance.

How long do I have to file a claim?
Deadlines vary by state and are governed by statutes of limitations. Some states also have statutes of repose for medical devices. Acting quickly helps preserve evidence and protect your rights.

What compensation may be available?
Compensation may include reimbursement for medical bills, rehabilitation costs, lost wages, long-term care, and pain and suffering. In severe cases, families may pursue wrongful death claims.

How do I know if the recalled pump was used in my treatment?
Medical records, hospital equipment logs, and device tracking information can identify whether the Ivenix Large Volume Pump was involved. An attorney can assist in obtaining and reviewing this documentation.

Contact Parker Waichman LLP For a Free Case Review

If you or a loved one suffered harm during infusion therapy involving an Ivenix Large Volume Pump, you may have legal options. Parker Waichman LLP is investigating claims related to this FDA Class I recall. The firm offers a free consultation to review your case and explain your rights.

Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. There is no obligation, and you pay nothing unless compensation is recovered. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.