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Issue

One customer required a specialty filter to be used for the infusion of an oncology product.  The filter was attached to pumps currently in use in a lengthy infusion process. The APT members needed to identify filter, provide samples for testing and assure worldwide clearance of product.  A product was identified and approved by APT Medical Director, tested and approved in the field.  Appropriate APT team members leveraged factory price points, forecasted field demand, and established inventory program for just-in-time delivery.

Field Issues and APT Response

	After three months, our customer notified the APT that a site in the EU was experiencing leakage issues after approximately 30 minutes of infusion.
	The APT Project Manager (PM) conducted worldwide site field surveys.  Results of the survey yielded no similar issues documented.  At the same time, the APT PM contacted the factory to report the quality issue.
	Product was returned from the site for Factory QA inspection procedure and new product was shipped so that the study continued without interruption.
	The site continued to have leakage.

APT Resolves the Problem

	Factory QA testing results indicated that the product was not defective and after further site investigations it was determined that clinicians were not following proper procedures for insertion of filter.
	The APT and the factory developed a “how to” guide for filter use in the field and conducted a site training seminars.
	APT translated in several languages and submitted the final copy to the customer for approval.
	The guide was released to the field.  The clinicians followed proper protocol and the leakage ceased to occur.

Note

This protocol continues and the original product identified by the APT remains a part of the process.