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Urgent Alert: Insulin Pump Tubing May Detach

Nov 25, 2014

Health Canada, Canada’s health regulatory agency, and manufacturer, Unomedical, have issued a safety alert to insulin pump users. There is a risk that in certain sets the tubing carrying the insulin may detach from the pump.

The potential safety issue involves certain models of infusion sets distributed by Medtronic of Canada, Roche Diagnostics, LifeScan Canada and Auto Control Medical.
"If tubing detachment occurs, insulin delivery is interrupted and the pump alarm will not notify the user, according to the manufacturer," according to Health Canada. "The risk to patients of an interruption in insulin delivery is hyperglycemia (elevated blood sugar levels)."

Hyperglycemia can result in diabetic ketoacidosis, a serious condition that in extreme cases can lead to death. Symptoms may include nausea, vomiting, shortness of breath and excess thirst/urination.

The manufacturer is advising patients to continue to use the infusion sets while following these directions.

  • When changing the infusion set, the patient should check the tubing connection location to make sure the tubing is not loose.
  • The patient should monitor blood sugar levels frequently using a blood glucose meter.
  • The patient should proactively check tubing connections occasionally to ensure tubing is secure. It is especially important to check blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
  • If a patient experiences high blood sugar, he or she check tubing connections and infusion site closely to ensure the tubing is secure.

A patient who discovers that the tubing is detached should not attempt to reattach the tubing, but should replace the infusion set immediately. The patient should treat high blood sugar as directed by a health care professional. Health Canada said patients who experience detached tubing should report the problem to the distributor and get instructions for how to return the defective set to the company.

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