IV Solutions Meant for Training Purposes Linked to Illnesses, Death: FDA

Following a recall of Wallcar sodium chloride IV bags, which are intended for training purposes only, federal health officials indicate that reports have been received that indicate hospitals administered the non-sterile solutions to patients intravenously, resulting in several illnesses and at least one death. 

The Wallcur’s Practi-0.9 sodium chloride IV bags are simulated IV bags intended for training and educational purposes only and are used for clinical simulation. The products are specifically labeled not to be used in humans or animals. Due to the fact that the products are not sterile, bacteria could be present that may cause someone to become ill or create a far more hazardous situation with an existing illness that could lead to adverse health consequences including death.

The training sodium chloride IV bags were recalled on January 7, after the FDA determined there is a safety risk where hospitals may mistake the simulation bags for real solutions and administer them to patients.

This week, the FDA announced an an investigation into reports that suggest more than 40 patients received infusions of the simulated saline, resulting in adverse events like fever, chills, tremors and headache. As a result of the problems, some patients have been hospitalized and at least one death has been reported.

The FDA is investigating how the IV bags meant for training purposes entered the medical supply chain. Most facilities that received the solutions have indicated that they were unaware that the IV solution bags were not for medical use, according to the FDA.

The recall includes Wallcur’s Practi-0.9% sodium chloride IV bags supplied in 50 mL, 250 mL, 500 mL, and 1000 mL sizes and the Practi-0.9% sodium chloride 100mL IV solution bag sterile distilled water. Wallcur began shipping the products on May 22, 2014, to medical clinics, surgical centers, and urgent care facilities in numerous states.

The FDA is working with the U.S. Centers for Disease Control and Prevention and Wallcur to identify all distributors who sold the simulated IV products and clinics that purchased and administered the solutions to patients to determine how the simulated products entered the supply chain for medical use.

Wallcur intends to add product enhancement labels containing similar language to the IV bags for future distributions to ensure there is sufficient and noticeable warning for the solutions not to be used on humans or animals.

The FDA has also announced guidelines for healthcare providers and clinicians to visually inspect all current IV saline solutions bags and remove and quarantine any bags that are labeled “Wallcur”, “Practi-Products”, or “For clinical simulation”, or “Not for use in human or animal patients”. After identifying the simulated products, healthcare providers should quarantine the products and contact Carla Sanderson at 619-702-4333 for further instruction.

Any patient who believes they may have received an injection of Wallcur simulated IV solution should contact their healthcare provider. The FDA believes those who were injected with the solutions would have most likely experienced symptoms immediately but out of precaution should still seek medical attention.