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FDA Warning for Training IV Solution Given to Patients

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December 31, 2014 — The FDA has received reports of patients who were seriously injured when they were administered an intravenous (IV) solution that was only intended for training purposes, and they are alerting healthcare professionals about the danger.

The agency is particularly concerned about Practi-IV Solution Bags, which are sold by Wallcur, LLC. The bags are prominently marked with “Practi-0.9% Sodium Chloride” and may also be marked with “for clinical simulation.”

They are supposed to be used on mannikins for training IV administration by nurses, pharmacists, EMT, and other health professionals. The bags do not actually contain saline, but only distilled water.

The FDA recommends:

“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.”

The solution is usually administered to patients who are suffering from electrolyte imbalances, fluid replacement for the treatment of dehydration, delivery of medications, and blood transfusions.

Patients who need a saline solution but are given water may develop serious side effects. Electrolytes are essential in the heart, nerves, and muscle cells. They transmit electrical impulses to other cells and maintain voltages across cell membranes.

If a patient with an electrolyte imbalance was given distilled water instead of a 0.9% saline solution, they could have problems maintaining homeostasis in their body. This could result in severe, life-threatening cardiovascular and neurological complications.

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