[Updated: 04/08/15] FDA’s laboratory analysis of Wallcur’s simulated Practi-0.9% sodium chloride IV is now complete. FDA sampled 11 of Wallcur’s simulated saline solution bags and identified large amounts of endotoxin and significant bacterial contamination in the samples.
These include bacteria (e.g., Bacillus spp., Brevundimonas sp., Pseudomonas spp., Rhizobium radiobacter, Sphingomonas koreensis, Sphingomonas trueperi, Sphingobium sp.). It is possible that additional bacteria are present in other bags that were not included in this analysis.
Laboratory testing confirmed that samples of Wallcur’s simulated Practi-0.9% sodium chloride IV solution products that FDA tested do NOT contain:
- yeast or mold;
- significant levels of lead, arsenic, cadmium, cobalt, chromium, nickel, selenium, thallium, or vanadium;
- drugs or poisons;
- dioctyl phthalate (plasticizer).
FDA is aware of more than 40 individuals who received infusions of the simulated Practi-0.9% sodium chloride IV products; 26 of whom reported adverse events that ranged from flu-like symptoms to sepsis, a potentially life-threatening complication of an infection. Of those 26 individuals, 2 deaths and 11 hospitalizations were reported.
FDA is reiterating its previous recommendations that ask health care professionals and consumers to do the following:
- Visually inspect all current IV solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-0.9% sodium chloride,” or “For clinical training purposes only”;
- Consider reviewing clinic procedures and make sure there are procedures in place to visually inspect all future shipments of IV products to ensure they are appropriate for patient use;
- Seek medical attention if you were given a simulated Practi-0.9% sodium chloride product and you experience the symptoms described above;
- Report any suspected adverse events associated with accidental or intentional exposure to simulated products to FDA’s MedWatch program online or at 1-800-332-1088.
FDA has been working closely with Wallcur to make changes to its labeling and distribution practices to prevent future occurrences. FDA also has been working with the simulation medical products industry to highlight the risks associated with the incorrect use of these products.
FDA’s investigation into how simulation products entered the clinical supply chain, including any potential role played by recent national shortages in saline for infusion, is ongoing.
[Updated: 01/30/15] FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate multiple instances of simulated saline solution being administered to patients and to alert health care providers and regulatory officials throughout the country to raise awareness of the potential risk.
FDA first became of aware of adverse events at two clinics associated with the mistaken administration of Wallcur’s simulated Practi-0.9% sodium chloride IV in late December and issued a warning to all health care providers not to inject these simulated products in humans or animals on December 30, 2014. FDA’s warning was disseminated through MedWatch and other communications channels, reaching more than 400,000 subscribers and followers.
- Recalled all Practi-0.9% sodium chloride IV bags supplied in 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL sizes
- Notified all customers and distributors who received recalled products
- Added stickers to existing packaging and labeling of Practi-0.9% sodium chloride IV bags to explicitly warn users that the simulated products are not intended for human or animal use and are for training purposes only
- Continued discussions with FDA concerning labeling recommendations for all simulation products
- Be vigilant and report any suspected adverse events following use of these products to FDA’s MedWatch program online or at 1-800-332-1088
- Visually inspect all current IV saline solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-0.9% saline,” or “For clinical training purposes only”
- Consider reviewing clinic procedures and make sure there are procedures in place to visually inspect all future shipments of IV products to ensure they are appropriate for clinical use
[Updated: 01/14/15] FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals.
Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution, was shipped to medical clinics, surgical centers, and urgent care facilities in numerous states.
So far, more than 40 patients have received infusions of the simulated saline products, and there have been many adverse events associated with these incidents including fever, chills, tremors and headache. Some patients were hospitalized, and there is one death associated with the use of these products; it is 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.
FDA, in partnership with CDC, has collected samples of Wallcur Practi 0.9% Sodium Chloride from clinics and distributors. These products are being tested to learn if the products may have caused the adverse events in patients.
Wallcur initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions. Most medical facilities reported that they were unaware that the IV solution bags were simulation products. At least one clinic recognized the Wallcur product was a simulation product upon receipt, and returned it to the distributor.
FDA is working with distributors who sold the simulated IV products and clinics that purchased and administered the simulated IV products from Wallcur to determine how these simulation IV solution products entered the supply chain and subsequently were administered to patients.
While Sodium Chloride 0.9% Injection (IV normal saline) has been in tight supply, FDA has been working with manufacturers to increase supply. In addition, FDA is not objecting to the temporary distribution of additional IV normal saline from alternate sources Fresenius Kabi USA, Baxter Healthcare Corp., and B. Braun Medical Inc. Currently, there is supply available from several manufacturers as posted on FDA’s website.
Clinicians and office staff are encouraged to take steps to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into patients.
- Visually inspect all current IV saline solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients.”
- If you have products labeled with any of these words, or you suspect you may have received other products intended for training purposes, separate simulation products from existing inventory and contact your distributor for directions on how to return these products.
- If you have received Wallcur Practi-products by mistake, please contact the distributor, or Wallcur, LLC of San Diego for return instructions.
- Consider reviewing your office procedures and make sure there are procedures in place to visually inspect all future shipments of normal saline products to ensure they are for clinical use.
If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event:
- Evaluate all potentially exposed patients with new, or ongoing symptoms;
- Use appropriate treatment;
- Report suspected cases to the state health department; and
- Report any adverse events following use of these products to FDA’s MedWatch program online or at 1-800-332-1088.
- Patients who believe they received an injection of Wallcur simulated IV solution should contact their health care provider.
- Patients who received simulated IV saline almost immediately upon injection experienced fever, chills, muscle aches, headaches, and some required hospitalization. In most reported cases, these signs and symptoms were immediately recognized and patients received appropriate medical attention.
- You may also file a report of the incident through FDA’s MedWatch program, and assist the FDA with this ongoing investigation.
- If you know you will be receiving normal saline, ask your doctor or nurse to visually inspect the bag, and ensure they are using normal saline for human use. Ensure the bag is not labeled or printed with any of the following: “Wallcur,” “Practi-products,” “For clinical simulation” or “Not for use in human or animal patients.” If the saline bag contains any of these words, ask your health care provider NOT to administer the solution.
Wholesalers, Distributors, Suppliers
- Inspect your inventory and ensure you are not distributing simulated products as clinical use products.
- It is incumbent upon wholesalers, distributors, and suppliers to clearly and accurately label and distribute their products to prevent medical product mix-ups from occurring.
- If you suspect you may have distributed this product to clients by mistake, immediately attempt to recall the products and warn clients of the potential risks. You should also contact Wallcur, your distributor and file a report to FDA’s MedWatch program.
FDA warns health care professionals not to inject patients with IV solutions from Wallcur, of San Diego
[12/30/14] The U.S. Food and Drug Administration is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients. These products are for training purposes only.
Before administering IV solutions to patients, health care providers should carefully check the labels to ensure that the products are not training products, such as Practi IV Solution Bags marketed by Wallcur. Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.
FDA has become aware that some Wallcur training IV products have been distributed to health care facilities and administered to patients. There have been reports of serious adverse events associated with the use of certain of these products – i.e., Practi IV Solution Bags.
If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, please report the incident to FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
- Downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178
FDA will continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform health care professionals and state health departments.