40 patients mistakenly given unsterile intravenous fluid

Liz Szabo | USA TODAY

At least 40 patients mistakenly received unsterilized, "simulated" intravanous fluids -- meant for training only -- instead of the sterile saline solution normally given to people in the hospital, health officials said Wednesday.

Many of the patients became ill and one died, although doctors aren't sure that the unsterilized solution caused the death, according to the Food and Drug Administration. An unspecified number of patients were hospitalized. Many developed fevers, chills, tremors and headaches almost immediately.

Because the symptoms appeared right away, patients generally were able to get quick medical attention from the health professionals administering the solution, the FDA says. Health care providers and hospitals should carefully check all fluid bags to make sure they aren't training products, the FDA says. The agency also suggests that patients receiving IV saline should check to make the bag is labeled as sterile and is not a practice bag.



The practice products were distributed beginning May 22, according to San Diego-based Wallcur, which manufactures simulated saline and other training products. The FDA did not say when patients were mistakenly given the simulated solution.

Patients receive intravenous saline -- which is dripped slowly into veins in the arm -- for many reasons. For example, doctors may prescribe intravenous saline to patients who are dehydrated because of a stomach bug.

Simulated saline is sometimes used when nurses or other health professionals are practicing how to administer it to high-tech mannequins, says Paul Delmore, attorney for Wallcur. Simulated saline is often cheaper than normal saline.

Wallcur recalled the bags of simulated saline Jan. 7 after learning that "training products" were "not used for their intended purpose." In a statement, the company said, "Despite the fact that the products are intended 'for clinical simulation' only, we are aware of reports that these products have been used outside of their intended use and administered to patients."

Wallcur makes only training products and doesn't make normal saline or other medications, Delmore says. It doesn't sell to hospitals. Instead, it sells only to educational institutions, such as medical and nursing schools that it has "vetted" as legitimate. The company also sells to distributors.

Delmore says he doesn't know how the mix-up happened or how training products made their way from a distributor to a hospital. "To the extent that someone ordered this, it was not directly from our company," Delmore says.

Patients mistakenly received the simulated saline in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado, the FDA says.

"Most medical facilities reported that they were unaware that the IV solution bags were simulation products," the FDA said in a statement. "At least one clinic recognized the Wallcur product was a simulation product upon receipt and returned it to the distributor."

The FDA notes that there have been shortages of normal saline solution for the past year. To alleviate those shortages, the FDA has allowed companies to import bags of intravenous saline from factories in Europe.

Michael Carome, director of Public Citizen's Health Research Group, called the mix-up "outrageous."

Injecting someone with non-sterile fluids could cause serious bloodstream infections, if the fluids are contaminated with bacteria or the toxins that bacteria produce, says Carome, a physician.

"The system for protecting patients failed at multiple levels," Carome says.

First, Carome says, products should be labeled very clearly -- with bold, red letters -- to make it almost impossible for anyone to mix up a simulated solution with normal saline.

Delmore says Wallcur is working closely with the FDA and generally follows any advice they provide about labels.

Second, Carome says, the FDA failed because it didn't do more to notify both hospitals and consumers of the problem. The FDA's first notice was released Dec. 30, when many people were celebrating the holidays and may not have noticed it.

"They should have had a much more aggressive public relations campaign, using national news outlets, to get this message out," Carome says.

Third, those responsible for distributing the practice saline also failed to protect patients, Carome says.

"They never should have allowed these products to get into the supply chain," Carome says.

Lastly, hospital staff should have noticed that the practice bags weren't sterile, Carome says. Health care providers who administered the saline should have noticed that they were using practice bags.

"The absence of a sign that says, 'This product is sterile' is a warning sign," Carome says. He says health professionals should inspect bags of saline carefully, looking not simply at the label but also at the liquid itself to make sure there are no particles or anything else floating in the fluid.