FDA: Non-Sterile Solution Linked to Multiple Injuries, 1 Death
The U.S. Food and Drug Administration (FDA) announced Wednesday that multiple patients had fallen ill and at least one patient has died after receiving a non-sterile IV solution that is meant for training purposes only.
More Than 40 Patients Injected with Solution
According to Medscape, the Centers for Disease Control and Prevention (CDC) along with the FDA have identified at least 40 patients who received the simulated IV saline solution, Practi-.9% sodium chloride solution.
The FDA warns that the solution is not sterile and is not meant for use in patients or animals.
Instances have been reported in Colorado, Florida, Georgia, Idaho, Louisiana, New York, and North Carolina. Adverse events have included fever, chills, tremors, and headaches.
Several patients required hospitalization after receiving the simulated IV solution, and at least one death is associated with the solution. Tests to determine if the solution was a direct cause of death are ongoing.
Solution Subjected to Previous Recall
The FDA first issued warnings concerning the solution on December 30, 2014. A subsequent recall was issued on January 7.
Unfortunately, most hospitals and medical facilities were unaware that they had received the simulation solution, believing the products to be true IV products. Regulators have stated that only one clinic recognized the problem and returned the non-sterile solution.
Healthcare providers are now being urged to inspect their entire inventory of IV saline solutions. Clinicians should check labels for the following phrases:
- “For clinical simulation”
- “Not for use in human or animal patients”