After uncovering a handful of patient safety and cybersecurity risks in many of its infusion pumps over the last year, Baxter has now begun a recall of yet another product that works alongside those pumps.
The medtech giant’s latest recall concerns some of its solution sets, also known as IV sets, which connect patients to their prescribed IV bags and bottles of medications. It’s specifically focused on the Clearlink Basic Solution Sets with Duovent, a drug that’s used to open the airways.
According to Baxter, which first issued the recall notice (PDF) in early August, the company has received an increased number of reports of leaks in the Clearlink IV sets. As of this week, the FDA has categorized the recall as Class I, indicating a high risk of patient injury or death.
Leakages in the solution sets are potentially dangerous to both patients and healthcare providers. The sets are most often used to deliver hazardous drugs like those prescribed for chemotherapy, which can be toxic for and cause irritation in anyone who’s accidentally exposed to the drugs as they leak.
Additionally, a leak in the IV set could allow air to enter the device’s mechanism or the sterile fluid pathway, possibly causing an air embolism—where an air bubble enters and blocks a vein or artery—or a contaminated infusion. Those reactions could in turn interrupt or delay a patient’s needed therapy or prevent them from receiving the correct amount of medication.
To date, Baxter hasn’t received any reports of serious injuries related to the issue, but according to the FDA, it has sparked a total of 83 complaints not linked to injury or death.
The recall spans more than 511,700 of the Clearlink solution sets that were distributed between mid-October 2020 and the end of June 2022.
Despite the safety issues, Baxter said it will continue to manufacture and distribute the same model of the IV sets, since supply of replacement sets and valid alternatives is limited and because its infusion pumps can only be used with its own solution sets, with no available alternatives.
Because of those limitations, the company has recommended that customers who aren’t experiencing leaks in the drug delivery systems continue to use them, while keeping an eye out for any issues that may arise. Any leaking sets should be immediately returned to Baxter for investigation, and any unused sets can also be returned to the company.
In the meantime, the devicemaker said it’s working on developing corrective actions to resolve the issue. When those are ready, Baxter will send out a follow-up notification to affected customers with the updated instructions.