No patient injury nor patient information provided after attempts to obtain information.Product was not returned to 3m (b)(6) for evaluation although indicates sample is available.3m implemented a new dehp free material to enhance the material properties on all 3m ranger(tm) fluid warming disposable products in 2013.Subsequent to this change 3m received a higher trend of complaints applicable to leaks within selected areas of the disposable tubing connections.3m implemented a solvent improvement process in late 2015 to address this type of event.This improvement was to the solvent bond process to reduced leaks on all of the following areas; y-connector, drip chamber, bubble trap and tube fitting which are part of the high flow disposable set.The change was implemented to increase strength and to minimize leaks.3m continues to monitor their complaints to confirm the effectiveness of the changes made.The lot number indicated in this complaint would have been subject to the above change.
|