Insulin pump infusion sets manufactured by Medtronic of Canada Inc., Roche Diagnostics, LifeScan Canada Inc, and Auto Control Medical Inc. have a risk of tubing detachment, according to a safety notification issued by Unomedical a/s in consultation with Health Canada. The alert, dated November 21st, warns that there have been growing reports of tubing become detached from the connect/disconnect location.
Insulin pumps deliver insulin to diabetic patients through a catheter. They can be programmed to administer small doses of insulin continuously or a larger dose close to mealtime to control blood sugar.
According to the alert, patients will no longer receive insulin if tubing detachment occurs. Furthermore, the manufacturer states that the alarm will not sound to inform the user of tubing detachment. Diabetic patients who do not receive appropriate insulin therapy can suffer from hyperglycemia, or elevated blood sugar. This in turn can cause diabetic ketoacidosis, a serious and, in extreme cases, potentially fatal condition. Nausea, vomiting, shortness of breath and excess thirst/urination can all be signs of ketoacidosis.
The manufacturer has several recommendations for patients using the affected insulin pumps. Users are instructed to follow instructions closely while changing the infusion set, check the tubing at the site connector to ensure it is firmly connected and use a blood glucose meter to monitor blood sugar levels frequently. If users notice that their blood sugar is high, they should check their tubing connections.
If users discover that the tubing has detached, they should not attempt to reattach it and are urged to replace the infusion set immediately. Users are advised to use guidelines provided by their healthcare professional to then treat high blood sugar. The alert also instructs users who experience tubing detachment to call the appropriate distributor to report the issue and receive instructions on how to return the pump.