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Hospitals in several states unknowingly gave some of their patients bags of unsterile intravenous fluids, and the wrong product resulted in many patients being sickened and one even died. The U.S. Food and Drug Administration (FDA) reported that as many as 40 patients were sickened by the incident being repeated in multiple places.
The problem was that medical staff provided the patients with intravenous (IV) bags that were only intended to be used for training purposes. They were never made to actually be given to anyone.
After being given the wrong product, patients developed a wide range of symptoms almost immediately. The symptoms included fevers, chills, headaches and tremors, resulting in some of the patients requiring hospitalization. One death also resulted from the incident, and an investigation is being undertaken to determine if the wrong intravenous fluids were the cause.
Because most of the patients were in a medical facility when the symptoms began, they were able to receive treatment right away. Patients are normally given saline solutions for many reasons, including dehydration.
Working together, the Centers for Disease Control and Prevention (CDC) and the FDA have collected the bags for testing. The agencies want to determine for certain if the product is what caused the patients to become sickened so quickly.
Once the company learned of what happened in the incident, it voluntarily recalled the product that remained at various clinics, hospitals and distribution centers. The product is called Wallcur Practi 0.9 percent Sodium Chloride.
Hospitals in seven states have been affected. These include New York, Colorado, Idaho, Georgia, Louisiana, North Carolina, and Florida.
The company Wallcur only manufactures training equipment. This means that somewhere along the line, a distributor may have mixed up the order and medical facilities did not notice the error. One facility caught the mistake and sent the product back to the distributor immediately.
The FDA stated that there has been a shortage of saline solution in the U.S. recently, starting about two years ago. In order to meet the demand, the FDA allowed U.S. suppliers to get the needed products from Europe.
After learning of the situation, the director of the Public Citizen’s Health Research Group, Dr. Michael Carome, called it “outrageous.” He then faulted “the system” at three levels, stating that the manufacturer should have labeled the training products more boldly; the FDA should have passed warning about the product more clearly; and for the medical facilities’ staff involved for not reading labels more carefully. He also said that the distributor is at fault for allowing it into the system.
The IV bags were sent to distributors on May 22, 2013. The company does not even sell its product to hospitals, but only to training institutions. These institutions buy the practice bags because they are considerably less expensive than the real saline solution IV bags, which are sterile.
Dr. Carome also mentioned that the unsterile fluids in the intravenous bags could easily cause patients to be sickened, and possibly even get severe bloodstream infections when given the wrong product. Doctors and nurses at hospitals need to be more careful about ensuring the right products are given to patients, he said.
By Mike Valles