Potentially Deadly Medical Software Defect Leads to Recall by Baxter Healthcare

On July 7, 2021, Baxter Healthcare had to recall one of its software programs due to a defect that can cause fatal injury or death. The product in question is the Dose IQ Safety Software, which is a standalone, computer-based software program that healthcare providers use to store dosing information for their patients.

Some healthcare providers have also paired the program with the Spectrum IQ Infusion System, which is a deadly combination for patients. All drug libraries that were initially created with Version 9.0x are at risk of suffering from issues such as mismatched drug information. The software program was distributed from February 1, 2018 – January 1, 2019; since its distribution period, 61 of the programs used with Spectrum IQ Infusion System have been recalled in the United States.

How is the software program used?

Healthcare providers use the Dose IQ Safety Software program to create a drug library of pre-programmed dosing information for specific medications and to assist healthcare providers in administering the doses to the patient. The Spectrum IQ Infusion pump attached to the software program delivers the pre-programmed medications into the person’s body in controlled amounts.

What are infusion pumps?

Infusion pumps are medical devices that healthcare providers use to deliver fluids into a patient’s body in a controlled manner. These devices are able to deliver fluids in large or small amounts, and many healthcare providers use these devices to administer nutrients and medications to their patients.

Although healthcare providers depend on infusion pumps to administer the necessary amounts of medications and nutrients to their patients, these devices can experience errors such as broken components, alarm errors, battery failures, and software problems. In fact, the current issue with the Dose IQ Safety Software program includes an issue with the software program.

Why is the software being recalled?

Manufacturers have discovered a software defect within the program that may cause serious injury or death to a patient. This software defect can cause mismatched drug information in the drug libraries created using the version 9.0x of the computer-based software. If the software’s drug identifier fails to match the drug information in the pump, the drugs can become improperly configured and cause several dangerous consequences such as delay in therapy, under-infusion, or over-infusion of medication.

Delay in therapy

A delay in therapy is an act of negligence where a healthcare provider fails to administer proper treatment to a patient in the time frame that treatment was supposed to be delivered. Treatment can mean a broad scope of items for a patient, such as a lab test, medication, or a physical therapy treatment. In some scenarios, delay in therapy can apply to failing to schedule an initial appointment or even a follow-up appointment in a timely manner.

Delay in therapy can lead to several fatal consequences for a patient. In terms of not receiving proper medication in a timely manner, the patient’s condition can worsen. Depending on the condition, the patient can lose permanent motor function; and in the worst case scenario lose their life.

Infusion errors

Infusion errors such as over-infusion and under-infusion can cause fatal consequences for patients. Over-infusion involves more fluid or medication being delivered to the patient than intended. Under-infusion involves less fluid or medication being delivered to the patient than intended. No matter the incident, both situations can create significant amounts of pain for patients. Depending on the patient’s condition, the likelihood of fatal injuries can increase due to either over-infusion or under-infusion.

What should I do if I received a letter from Baxter Healthcare?

In July, Baxter Healthcare published an Urgent Medical Device Correction Letter to all customers with detailed instructions on how to handle the recall. These instructions are especially beneficial to healthcare providers who are currently using the Spectrum IQ Infusion System with the Dose IQ software version 9.0x, and patients who require care using the Spectrum IQ Infusion System pumps with the Dose IQ software version 9.0x. Healthcare providers are instructed to:

• Program the pump in Basic Mode if the desired drug concentration and delivery mode is not identified during pump programming.
• Notify the pharmacy department if a drug configuration is not found on the pump. In this event, pharmacy departments are required to contact Baxter Technical Assistance if a missing drug configuration in the infusion pump happens to be found in the Dose IQ computer software and the drug library was created with version 9.0x.
• Customers may not be familiar with the drug mismatch problems. Because of this, healthcare providers are advised to practice heightened awareness should they continue to use Dose IQ 9.0x. Caution must be exercised while using Dose IQ 9.0x if an alternative is not available.
• Customers should complete the Customer Reply Form attached to the Urgent Medical Device Correction letter and return it by email to fca@baxter.com.

Additional action taken by Baxter Healthcare

Baxter Healthcare has also notified the general public that the company is currently working on a standalone validated software tool to identify linked drug entries that are affected by this issue. A Baxter representative will reach out to facilities to create a correction plan once the tool becomes available for use. Affected customers will also be upgraded to the Dose IQ version 9.1.1 or higher.

Please contact Paulson & Nace, PLLC through this contact form or by calling 202-463-1999.