Baxter Healthcare Corporation Provides Revised Guidelines for Usage

Baxter Healthcare Corporation Provides Revised Guidelines for Usage

Baxter Healthcare Corporation Provides Revised Guidelines for Usage

This recall pertains to modifications in the instructions for device usage, rather than the removal of these devices from sale or usage points. The FDA has classified this recall as the highest level of concern. Using the device without adhering to the revised instructions poses serious risks, potentially leading to severe injury or even mortality.

Product Details

Illustration of the devices. H938173, non-vented high volume inlet. H938174, vented high volume inlet. H938175, vented micro volume inlet. H938176, micro volume inlet with luer lock end.
  • Product Names: Automated Compounding Device Inlets (disposable inlet) utilized with ExactaMix and ExactaMix Pro.

Necessary Actions

  • Examine disposable inlets before use, including their primary packaging, tubing, connectors, and spikes.
  • If you find any particulate matter, do not utilize the inlet.

The ExactaMix and ExactaMix Pro compounding devices remain usable with inlets free from particulate matter.

On August 20, 2024, Baxter Healthcare Corporation dispatched an Urgent Medical Device Correction letter to all affected customers, outlining the following actions:

Instructions for Pharmacy and Clinical Personnel

  • Assess inlets prior to use, referencing the letter’s guidance.
  • Should any particulate matter be detected, refrain from using the inlet.
    • Contact Baxter Corporate Product Surveillance to report the issue and arrange for product return for examination.
      • Have the Baxter 8-digit ship-to account number, product code, lot number, and return quantity ready upon contacting Baxter. Product code and lot number can be found on the product pouch and carton.
  • If the inlet appears free of particulate matter, proceed to use it.
    • Follow the priming instructions outlined in the Priming and Verifying section of the ExactaMix and ExactaMix Pro compounder Operator’s Manual, ensuring to visually check for particulates during the priming process and avoid use if any are found.
  • Inspect the final solution in the patient bag for any precipitates and particulates post-compounding as instructed in the Fulfilling the Order section of the Operator’s Manual. Should any particulate matter be evident, it is advisable not to use the solution. Multiple professionals should ideally verify the final product (like a pharmacist during compounding and a nurse before delivery to the patient).
  • Employ a minimum of a 1.2 micron in-line filter during administration.
    • The American Society for Parenteral and Enteral Nutrition (ASPEN) suggests using a 1.2 micron in-line filter for administration related to total nutrient admixtures (TNAs), dextrose-amino acid mixtures, and lipid injectable emulsions. If this filtration is already in practice as per ASPEN’s guidelines, no further action is required.
    • Use at least a 1.2 micron in-line filter for any solution that utilizes the Compounding Device Inlets. This includes various types of solutions, although some may involve smaller filter sizes as standard procedure.

Instructions for Consumers

  • Disseminate this information to all personnel working with ExactaMix and ExactaMix Pro compounders and related products (pharmacy and clinical staff).
  • Adhere to steps for inspecting, priming, and in-line filtration until a suitable replacement becomes available.
  • If you directly received this notification from Baxter, acknowledge receiving it through the Baxter customer portal, even if you lack inventory. https://BaxterFieldActionCustomerPortal.onprocess.com
    • Log in with the account number provided in the attached reply form. Acknowledgment will prevent you from receiving duplicate notices.
  • Forward this communication to other departments or facilities that may have received this product via distribution.
  • Distributors and related parties should inform their customers regarding this Urgent Medical Device Correction following standard policies and mark it accordingly on the customer portal.

Rationale Behind Updated Instructions

Baxter Healthcare Corporation is revising usage guidelines due to an uptick in malfunction reports involving particulate matter discovered within the primary packaging of the inlet components, including the sterile fluid path tubing. This issue is isolated to the disposable inlets and does not extend to the ExactaMix or ExactaMix Pro devices themselves.

Utilizing the affected product could lead to serious health consequences, including pulmonary embolism, strokes, damage to small blood vessels and organs, severe injuries, and potential fatalities.

No injuries or fatalities have been reported thus far.

Device Functionality

The ExactaMix and ExactaMix Pro Automated Compounding Device Inlet is classified as a disposable accessory for the ExactaMix and ExactaMix Pro systems. These devices are utilized in pharmacies to merge various components into one cohesive solution and are not intended for direct connection to patients. They are strictly for use with their respective compounding devices.

Contact Information

For inquiries regarding this recall in the U.S., reach out to Baxter Healthcare Center for Service at 888-229-0001.

Comprehensive List of Affected Devices

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) is crucial for tracking medical devices from inception to end-user application in the U.S. It enhances the accuracy of reporting and analysis concerning adverse effects, facilitating quicker identification and resolution of potential device issues.

How to Report Concerns?

Healthcare providers and consumers are encouraged to report any adverse events or product quality concerns they encounter while using these devices through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.