Investigation of simulated saline continues

Wallcur IV solution

Credit: FDA

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are still investigating multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients.

So far, more than 40 patients have received infusions of Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution, which is intended for training purposes only. The product is not sterile and should not be injected in humans or animals.

There have been many adverse events associated with the infusions, including fever, chills, tremors, and headache. Some patients were hospitalized, and there has been 1 death, although it’s not clear if this death is directly related to the product.

Adverse events have been reported in 7 states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.

The FDA, in partnership with the CDC, has collected samples of Wallcur Practi 0.9% sodium chloride solution from clinics and distributors. These products are being tested to determine if they caused the adverse events observed in patients.

In addition, Wallcur has initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions.

Most medical facilities that received the product said they were unaware that the IV solution bags were simulation products. However, at least one clinic recognized the Wallcur product was a simulation product upon receipt and returned it to the distributor.

The FDA said it is working with distributors who sold the simulated IV products and clinics that purchased and administered the products from Wallcur to determine how these products entered the supply chain and were administered to patients.

While Sodium Chloride 0.9% Injection (normal saline) has been in short supply, the FDA has been working with manufacturers to end the shortage.

The FDA has allowed the temporary distribution of additional IV normal saline from alternate sources: Fresenius Kabi USA, Baxter Healthcare Corp., and B. Braun Medical Inc. Currently, normal saline is available from several manufacturers, as posted on the FDA’s website.

FDA recommendations

The FDA is encouraging healthcare providers to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into patients.

Providers should visually inspect all current IV saline solution bags to 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 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
• Report any adverse events following the use of these products to the 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 healthcare provider.

Patients who received simulated IV saline experienced fever, chills, muscle aches, and headaches almost immediately upon injection, and some required hospitalization. In most reported cases, these signs and symptoms were immediately recognized, and patients received appropriate medical attention.

Wholesalers, distributors, and suppliers of IV saline products should inspect their inventory to ensure they are not distributing simulated products as clinical-use products.

If you suspect you may have distributed Wallcur simulated IV solution to clients by mistake, immediately attempt to recall the products and warn clients of the potential risks. You should also contact Wallcur and your distributor and file a report with the FDA’s MedWatch program.

Wallcur IV solution

Credit: FDA

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are still investigating multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients.

So far, more than 40 patients have received infusions of Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution, which is intended for training purposes only. The product is not sterile and should not be injected in humans or animals.

There have been many adverse events associated with the infusions, including fever, chills, tremors, and headache. Some patients were hospitalized, and there has been 1 death, although it’s not clear if this death is directly related to the product.

Adverse events have been reported in 7 states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.

The FDA, in partnership with the CDC, has collected samples of Wallcur Practi 0.9% sodium chloride solution from clinics and distributors. These products are being tested to determine if they caused the adverse events observed in patients.

In addition, Wallcur has initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions.

Most medical facilities that received the product said they were unaware that the IV solution bags were simulation products. However, at least one clinic recognized the Wallcur product was a simulation product upon receipt and returned it to the distributor.

The FDA said it is working with distributors who sold the simulated IV products and clinics that purchased and administered the products from Wallcur to determine how these products entered the supply chain and were administered to patients.

While Sodium Chloride 0.9% Injection (normal saline) has been in short supply, the FDA has been working with manufacturers to end the shortage.

The FDA has allowed the temporary distribution of additional IV normal saline from alternate sources: Fresenius Kabi USA, Baxter Healthcare Corp., and B. Braun Medical Inc. Currently, normal saline is available from several manufacturers, as posted on the FDA’s website.

FDA recommendations

The FDA is encouraging healthcare providers to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into patients.

Providers should visually inspect all current IV saline solution bags to 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 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
• Report any adverse events following the use of these products to the 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 healthcare provider.

Patients who received simulated IV saline experienced fever, chills, muscle aches, and headaches almost immediately upon injection, and some required hospitalization. In most reported cases, these signs and symptoms were immediately recognized, and patients received appropriate medical attention.

Wholesalers, distributors, and suppliers of IV saline products should inspect their inventory to ensure they are not distributing simulated products as clinical-use products.

If you suspect you may have distributed Wallcur simulated IV solution to clients by mistake, immediately attempt to recall the products and warn clients of the potential risks. You should also contact Wallcur and your distributor and file a report with the FDA’s MedWatch program.

Wallcur IV solution

Credit: FDA

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are still investigating multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients.

So far, more than 40 patients have received infusions of Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution, which is intended for training purposes only. The product is not sterile and should not be injected in humans or animals.

There have been many adverse events associated with the infusions, including fever, chills, tremors, and headache. Some patients were hospitalized, and there has been 1 death, although it’s not clear if this death is directly related to the product.

Adverse events have been reported in 7 states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.

The FDA, in partnership with the CDC, has collected samples of Wallcur Practi 0.9% sodium chloride solution from clinics and distributors. These products are being tested to determine if they caused the adverse events observed in patients.

In addition, Wallcur has initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions.

Most medical facilities that received the product said they were unaware that the IV solution bags were simulation products. However, at least one clinic recognized the Wallcur product was a simulation product upon receipt and returned it to the distributor.

The FDA said it is working with distributors who sold the simulated IV products and clinics that purchased and administered the products from Wallcur to determine how these products entered the supply chain and were administered to patients.

While Sodium Chloride 0.9% Injection (normal saline) has been in short supply, the FDA has been working with manufacturers to end the shortage.

The FDA has allowed the temporary distribution of additional IV normal saline from alternate sources: Fresenius Kabi USA, Baxter Healthcare Corp., and B. Braun Medical Inc. Currently, normal saline is available from several manufacturers, as posted on the FDA’s website.

FDA recommendations

The FDA is encouraging healthcare providers to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into patients.

Providers should visually inspect all current IV saline solution bags to 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 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
• Report any adverse events following the use of these products to the 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 healthcare provider.

Patients who received simulated IV saline experienced fever, chills, muscle aches, and headaches almost immediately upon injection, and some required hospitalization. In most reported cases, these signs and symptoms were immediately recognized, and patients received appropriate medical attention.

Wholesalers, distributors, and suppliers of IV saline products should inspect their inventory to ensure they are not distributing simulated products as clinical-use products.

If you suspect you may have distributed Wallcur simulated IV solution to clients by mistake, immediately attempt to recall the products and warn clients of the potential risks. You should also contact Wallcur and your distributor and file a report with the FDA’s MedWatch program.