FDA Safety Alert for Wallcur Practi-IV Training Solution

December 31, 2014 — The FDA is warning that they have received adverse event reports when patients were administered intravenous (IV) solution made by Wallcur, LLC, that is only intended for training purposes.

The products and are not intended to be given to patients. The FDA has become aware that some Wallcur training IV products were distributed to healthcare facilities and administered to patients, resulting in serious injury.

The FDA warns healthcare professionals:

“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 training products might be marked with “for clinical simulation.” They are prominently marked with “Practi-0.9% Sodium Chloride” in large blue letters at the top of the bag.

The Practi-IV solution bags simulate 0.9% sodium chloride, but contain distilled water. They are intended to simulate administration of an IV solution for nursing, pharmacy, EMT, or other health professionals in training. The saline solution may be used to correct electrolyte imbalances, deliver medications, for blood transfusions, or as fluid replacement to correct dehydration.

Electrolytes are essential because they are necessary for nerve, heart, and muscle cells to maintain voltages across their cell membranes and carry electrical impulses to other cells.

Patients with electrolyte imbalances who are administered only water, as opposed to saline, may have problems maintaining homeostasis in the body. This can lead to severe, life-threatening side effects in the cardiovascular and neurological systems.