UPDATE: March 14, 2022: FDA has classified Baxter International's infusion pump recall, impacting more than 270,000 devices in the U.S., as a Class I event.
The agency on Friday labeled it the most serious type of recall given that Baxter has received 51 reports of serious injuries and three reports of patient deaths over a five-year period. The recall labeling follows a safety notification put out by the FDA in February.
FDA said "use of the affected products may cause serious adverse events" potentially associated with an issue with the infusion pumps "not delivering medication at the programmed rate displayed on the screen, and in some cases may not alarm for upstream occlusions."
Baxter in late December sent an urgent safety communication to affected customers about its Spectrum V8 and Spectrum IQ infusion pumps used to deliver IV medications and other fluids to patients.
At the time, Baxter informed clinicians that they can continue to use the pumps in hospitals and other healthcare facilities, provided they follow on-screen instructions and upstream occlusion alarm troubleshooting in the operator's manual.
- In an urgent safety communication, Baxter International warned that its infusion pumps were not alarming if patients were receiving too little or no medication. The problem stems from users not properly setting up the device or not resolving previous alarms, which can result in an elevated baseline reading for the device's upstream occlusion pressure sensor.
- Baxter first warned of the problem at the end of 2021, which applies to its Spectrum V8 and Spectrum IQ infusion pumps used to deliver IV medications and other fluids to patients in controlled amounts. Over the last five years, it has resulted in 51 reports of serious injury and three patient deaths.
- Clinicians can continue to use the devices. Baxter wrote in an email that it had contacted all customers to reinforce important safety information and would send a follow up letter to communicate further details on actions the company is taking to resolve this issue.
Baxter first warned about problems with its Spectrum V8 and Spectrum IQ infusion pumps in a safety communication on Dec. 29, 2021. The company noted that the pumps would not sound an alarm if a blockage was preventing medication from flowing to a patient, caused by previous alarms not being resolved correctly.
The problems affects more than 140,600 Sigma V8 infusion systems and more than 175,000 Spectrum IQ pumps.
According to Baxter, providers can continue to use the pumps, but must follow on-screen instructions and in the operator's manual. For instance, they should check that all clamps are open, that there are no kinks in the tubing and confirm fluid flow before infusion and during an occlusion alarm.
Baxter did not specify whether it plans to make updates to its user manual, but the company said in an email to MedTech Dive that "we are working with FDA to address this issue and will communicate directly with customers regarding any further actions, including possible labeling updates."
This isn't the first time that infusion pumps have come under scrutiny. In 2020, Baxter recalled three of its infusion pumps due to unplanned device shutdowns. According to the company, improper cleaning of the devices could lead to corrosion or residue build-up, which could result in an unplanned shutdown if the device is running on battery power.
Patient safety nonprofit ECRI listed damaged infusion pumps as one of its top medical device safety hazards for 2022, noting that improper cleaning, mishandling or poor device design can result in patients not receiving the correct flow of medication. According to an ECRI alert, one of its member hospitals reported multiple incidents of a significant delay to an upstream occlusion alarm.
A little over a decade ago, the FDA flagged "significant safety issues" with infusion pumps, noting that some adverse events may be the result of user error, but many of them are also related to deficiencies in device design and engineering. Around that time, the agency rolled out an infusion pump improvement initiative, asking manufacturers to include more safety information in their premarket submissions, and launching a series of inspections, starting in 2011.