Dear Valued Customer,
Recent improvements in our Quality System have been implemented at our Maquet Cardiopulmonary world-wide facilities which have led to changes in some of the processes. MCP has become aware that its sampling plans for endotoxin testing on products labeled “non-pyrogenic” were not compliant with USP Requirements for Endotoxin on Medical Devices and ANSI/AAMI ST72: 2011 Bacterial Endotoxins – Test Methods, routine monitoring, and alternatives to batch testing. Since the lapse in testing was discovered, MCP has performed a gap assessment and implemented a statistically valid sampling plan.
As a result of the changes required in sampling plans, and in an effort to ensure the highest quality standards, Custom Tubing Packs will face a prolonged manufacturing delay. Because we are unable to provide specific timelines for product availability of our Custom Tubing Packs, our Territority Managers will work with you to help identify alternative solutions to meet the needs of your hospital.
Please note, to further assist you and, as an interim solution, we are able to supply our QUADROX oxygenators and/or our ROTAFLOW disposable pumps separate from the Custom Tubing Packs. These devices will have been tested for endotoxins using a statistically valid sampling plan. You are encouraged to seek an alternate vendor to meet your immediate tubing pack needs.
Philip B. Freed MS, PA-C
Chief Commercial Officer, Commercial Operations