The FDA and the CDC are continuing to investigate multiple instances of Wallcur’s practice intravenous saline products being administered to patients. These products are not sterile and should not be injected in humans or animals. They are for training purposes only.
Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution, was shipped to medical clinics, surgical centers, and urgent care facilities in numerous states.
So far, more than 40 patients have received infusions of the simulated saline products, and there have been many adverse events associated with these incidents including fever, chills, tremors, and headache. Some patients were hospitalized, and there is one death associated with the use of these products. It is not known if this death is directly related to the use of the product. Adverse events have been reported in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
The FDA, in partnership with the CDC, has collected samples of Wallcur Practi 0.9% Sodium Chloride from clinics and distributors. These products are being tested to learn if the products may have caused the adverse events in patients.
Wallcur initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions. Most medical facilities reported that they were unaware that the IV solution bags were simulation products. At least one clinic recognized the Wallcur product was a simulation product upon receipt and returned it to the distributor.
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, the FDA is not objecting to the temporary distribution of additional IV normal saline from alternate sources-- Fresenius Kabi USA, Baxter Healthcare Corp., and B. Braun Medical Inc.
Before administering IV solutions to patients, health care providers should carefully check the labels to ensure that the products are not training products, such as Practi IV Solution Bags marketed by Wallcur. Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.
See the FDA Drug Safety Announcement
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe
See also Medical Law Perspectives, March 2012 Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?