FDA Alert: Baxter Solution Sets

On December 31, 2024, the Food and Drug Administration (FDA) issued an early alert regarding solution sets manufactured by Baxter Healthcare Corporation (Baxter). This alert followed a December 20, 2024, letter sent by Baxter to affected healthcare providers advising them to stop using certain Solution Sets with Duo-Vent Spikes due to a potentially high-risk device issue. According to Baxter, affected solution sets were improperly assembled with inverted slide clamps. If a solution set with an inverted slide clamp is used with an infusion pump, medication may not be delivered, and the patient’s blood may flow back into the solution container. 

The FDA alert advised that the use of defective solutions sets may result in serious patient safety effects, especially in high-risk or vulnerable populations. Baxter has not reported any serious injuries associated with this issue to date, but organizations that have these products should immediately stop using them and return them to the manufacturer. 

If your organization uses Baxter Solution Sets with Duo-Vent Spikes, take the following immediate steps:

• Review the FDA alert. The alert contains more details on this issue and identifies the product codes, lot numbers, expiration dates, and unique device identification (UDI) numbers of the affected products. Notify all potentially affected departments within your organization.
• Inspect your inventory. Immediately inspect your drug inventory to ensure it does not contain the products identified in the alert. Notify all providers who use Baxter Solution Sets with Duo-Vent Spikes about the issue and the associated alert. Instruct them to immediately stop using these products.
• Remove the affected items from stock. Remove affected products from inventory and keep them in a safe place that cannot be accessed for patient use. Notify the FDA, manufacturer, and wholesaler, and await further instructions for disposition of the affected inventory. Ensure replacement product availability to avoid delays in care.
• Monitor. If any patient has been affected by this issue, notify risk management personnel and your professional liability carrier for further instructions. 
• Review processes. Take this opportunity to review your policies and procedures regarding management of medication, device, and equipment recalls. Ensure you are responding to product notices and recalls in a timely fashion to enhance patient safety.