Back on December 30th, FDA alerted health professionals about a patient who became ill after receiving an IV solution meant for training purposes only. Educators often utilize training products for simulations with students and want these items to look like the real solutions. However, there have been serious adverse events associated with misuse. These solutions aren't sterile and should never be used in humans or animals.
Since the initial alert we learned of additional patients who received these solutions since the earlier alert and late Wednesday evening FDA published a statement saying that over 40 patients have actually received these solutions, many suffering adverse events, including fever, chills, tremors and headache. Some patients were hospitalized, and there is one death associated with the use of these products although it's 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.
These events may be related in part to IV saline product shortages that hospitals have been dealing with over the past few months. Supplies from B. Braun, Hospira, and Baxter have been spotty. Purchasers looking for replacement supplies may have confused these training products with the real thing, and then ordered them through their distributors. Although distributor listings state that these are training products, purchasers may not recognize this and the solutions may have then been misidentified upon arrival at the healthcare facility. Subsequently, internal distribution took place, and the fact that these were training products was overlooked. Since staff may be having trouble getting their usual IV products, they may not be suspicious of the unusual labeling. Although each product is labeled "for clinical simulation," this may not always be recognized. (Also, "for clinical simulation" looks very close to "for clinical situations.")
In a media release, Wallcur, the manufacturer of the solutions noted in the FDA alert, said it has recalled current products, including Practi-0.9% sodium chloride IV bags supplied in 50 mL, 250 mL, 500 mL, and 1,000 mL sizes, and the Practi-0.9% sodium chloride 100 mL IV solution bag with sterile distilled water. The extent of distribution of these products is not fully known, but inpatient and outpatient locations have received supplies. The company told us that about 90% of the distribution of training products is via independent medical distributors, including some drug wholesalers. Supplies can also be purchased through the company's website, in which case they interact with the customer to assure use is for training purposes.
Wallcur is also working with FDA to identify ways to label these products to state more clearly that they are not to be used in humans or animals. Hospital educators, medical and nursing school affiliates, urgent care centers, ambulatory surgical centers, and other inpatient and outpatient facilities are being asked to assure all are aware of this situation, taking action where appropriate.
Anyone, including patients, that suspects any Wallcur training IV products (or training products from another manufacturer, such as Pocket Nurse Demo Dose) may have been administered to a patient, whether or not harm has resulted, should report it to FDA's MedWatch Adverse Event reporting here: MedWatch Online Voluntary Reporting Form. FDA will continue to investigate and monitor this issue.