The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals, the CDC says.
Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution, was shipped to surgery centers, medical clinics, and urgent care facilities in numerous states. At press time, more than 40 patients had received infusions of the simulated saline products, and there had been many adverse events associated with these incidents including fever, chills, tremors, and headache. Some patients were hospitalized. There is one death associated with the use of these products, but it is not known if this death is directly related to the use of the product. Adverse events have been reported in Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
Wallcur initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions. (For more on the recall, go to http://1.usa.gov/1uDUHZS.) Most medical facilities reported that they were unaware that the IV solution bags were simulation products. The FDA is working with distributors who sold the simulated IV products and clinics that purchased and administered the simulated IV products from Wallcur to determine how these simulation IV solution products entered the supply chain and subsequently were administered to patients.
While sodium chloride 0.9% injection (IV normal saline) has been in tight supply, the FDA has been working with manufacturers to increase supply. In addition, FDA is not objecting to the temporary distribution of additional IV normal saline from alternate sources: Fresenius Kabi USA (http://1.usa.gov/1D0prn1), Baxter Healthcare Corp. (http://1.usa.gov/189bqdl) or B. Braun Medical Inc. (http://1.usa.gov/1JiP4TU).
Staff are encouraged to take these steps to ensure IV solution simulation products are removed from inventory to eliminate the possible injection of simulated products into patients:
- Visually inspect all current IV saline solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients.”
- If you have products labeled with any of these words, or you suspect you might have received other products intended for training purposes, separate simulation products from existing inventory and contact your distributor for directions on how to return these products.
- If you have received Wallcur Practi-products by mistake, please contact the distributor or Wallcur of San Diego for return instructions.
- Make sure there are procedures in place to visually inspect all shipments of normal saline products to ensure they are for clinical use.
- If you suspect that any Wallcur training IV products might have been administered to a patient, whether or not the incident has resulted in an adverse event:
- Evaluate all potentially exposed patients with new or ongoing symptoms.
- Use appropriate treatment.
- Report suspected cases to the state health department.
- Report any adverse events following use of these products to the FDA’s MedWatch program online (http://www.fda.gov/Safety/MedWatch/default.htm) or at (800) 332-1088.