FDA upgrades Baxter infusion pump safety issue to Class I recall

As predicted, not long after Baxter International issued an urgent safety communication about an issue with some of its Spectrum infusion pumps, it has been upgraded to a full-blown recall complete with the FDA’s Class I label.

The recall pertains to the devicemaker’s Spectrum V8 and Spectrum IQ infusion pumps, which are used in clinical settings to automatically deliver medications, blood, nutrients and other fluids directly to a patient’s body through an intravenous line.

As detailed in the original safety notice (PDF), which was sent to healthcare providers at the end of December 2021, Baxter identified a technical issue with the devices that may keep them from emitting an alarm for repeated upstream occlusions—in which the system becomes blocked between the IV bag and the pump.

The recall encompasses more than 277,000 devices distributed in the U.S. between early 2015 and this year, according to the FDA.

Because infusion pumps are responsible for delivering such crucial fluids to patients, blockages anywhere in the system that cause an under- or over-delivery of the fluids can be potentially life-threatening.

So far, Baxter said it has received reports of more than 50 serious injuries and three deaths over the course of the last five years that may be associated with the issue. That explains why the FDA doled out its most serious Class I rating for the recall, denoting a high risk of injury or death.

Despite the recall, healthcare providers can still safely use the affected pumps if they follow all on-screen and safety manual instructions, the company said. They should be especially vigilant about resetting and restarting the pumps after an upstream occlusion alarm has occurred, since improperly set up pumps and unresolved previous alarms have been found to prevent future alarms from sounding. Baxter is not requesting that devices be returned to the company nor replaced.

The upgraded recall comes amid the release of a study highlighting another major safety issue with “smart” infusion pumps. In an analysis of data from more than 200,000 infusion pumps connected to hospital networks, Palo Alto Networks discovered more than 40 direct cybersecurity flaws.

Up to 75% of the devices may be vulnerable to digital attacks, the researchers concluded, ranging from the interception of unencrypted communications to potentially malicious changes to IV delivery settings.