Fresenius Medical

2008 Series Hemodialysis Addendum for Central Water Delivery System Rev A

Addendum for Central Water Delivery System

2 Pages

". ~ d  FRESENIUS MEDICAL CARE IMPORTANT INFORMATION - PLEASE READ Fresenius 2008 ® Series Hemodialysis Machine Communication April 25, 2014  Dear Medical Director, Clinic Manager, Clinical Manager and Technical Services Manager, Fresenius Medical Care North America mailed a communication and operator's manual addendum to you on April 9, 2014 related to loss of water pressure in a central water delivery system while disinfection is being performed on a 2008 Series hemodialysis machine. We are attaching a revised operator's manual addendum. The main change to this document is it now takes into account the variance of water system specifications and configurations that are present in clinics today. We have added the following statement: "However, facilities should make a determination on the poliCies and procedures required based on their individual water system specifications and configurations./I As the industry's leading provider of hemodialysis equipment, we are committed to providing the highest levels of equipment performance, support and service. Fresenius continues to investigate this situation and we thank you for your continued support of Fresenius Medical Care hemodialysis equipment. Sincerely,  Denise Oppermann Senior Director Regulatory Affairs - Devices Enclosures: One (1) Fax-back Form, One (1) Operator's Manual Addendum
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File Name: 2008_series_hemodialysis_addendum_for_central_water.pdf

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