Fresenius Medical
Hemodialysis Machine
2008 Series Hemodialysis Addendum for Central Water Delivery System Rev A
Addendum for Central Water Delivery System
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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
a 7 FRESENIUS
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MEDICAL CARE
2008® Series Hemodialysis Machine Operator's Manual Addendum for Central Water Delivery System Failure
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This is an addendum to the 2008 series Hemodialysis Machine Operator's Manuals: • 2008K Hemodialysis Machine Operator's Manual, PIN 490042 rev M • 2008K2 Hemodialysis Machine Operator's Manual, PIN 490136 rev G • 2008K@home User's Guide, PIN 490180 rev D • 2008T Hemodialysis Machine Operator's Manual, PIN 490122 rev L This addendum includes the following warning for machines connected to a central water delivery system: Warning! Failures in Cenh'al Water Delivery (CWD) systems may cause a loss of water pressure, It is suggested to not perform an Acid Clean, Chemical/Rinse or Chemical Dwell program on your machine whi le other patients are being dialyzed on machines connected to the same CWD system. If the CWD system is connected to hemodialysis machines running an Acid Clean, Chemical/Rinse or Chemical Dwell program when a loss of water pressure occurs, this may potentially cause these chemicals to be pulled into the CWD system and contaminate it. In the event of contamination, the entire system, including all attached equipment, should be purged, rinsed, and tested for residual chemicals, However, facilities should make a determination on the policies and procedures required based on their individual water system specifications and configurations,
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PIN 450416 Rev A