Post by Stuff on Jul 22, 2021 17:58:14 GMT
Fresenius Medical Care Renal Therapies Group, LLC
Corporate Headquarters: 920 Winter Street Waltham, MA 02451 (781) 699-9000
Pg. 1 of 3
IMPORTANT MEDICAL DEVICE CORRECTION
2008T® & 2008T BlueStar™ Machine
Remove USB Device 2 Alarm
Field Action Number: FA-2020-09-W_REV A_Software Now Available
Dear Valued Customer,
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG, LLC) sent you a notification on May 5, 2020 for a potential issue when using the 2008T or 2008T BlueStar hemodialysis machines. A “Remove USB Device 2” false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine. The May 5, 2020 communication indicated this software issue only pertained to CDX™ installed machines. However, this software issue affects all 2008T and 2008T BlueStar machines regardless.
We are pleased to notify you we have developed and are making available a software update Part Number 191137 REV F (software v.2.74) which will address the above situation. This software update is being provided to you at no charge.
This software will also include the additional features: *
• Installing this software update on non 2008T BlueStar machines will upgrade your machines to 2008T BlueStar’s standard software and features. 2008T BlueStar standard software only supports 45X concentrates.
• Crit-Line® Boundary Profile Lines
o See attached Biomed Notification.
• If 2008T BlueStar Premium is currently installed, this software upgrade will allow for a “Rinse” option with your Auto Start feature. This option is only available if you have 2008T BlueStar Premium currently installed.
PLEASE NOTE: Software update v 2.74 Part Number 191137 (REV F) will only support 45X concentrates.
* Please reference 2008T Hemodialysis Operator’s Manual for more information on these and other 2008T BlueStar features. You may download the Operators Manual from the Fresenius Medical Care Support Website: fmcna.com/support/
In order to receive software v 2.74 update:
Please go to the FIELD ACTION REGISTRATION SITE:
Access this site directly: fmc-rtg.force.com/FAUSB2 (link is case sensitive) or via the QR code below:
• PLEASE KEEP THIS NOTIFICATION AND MAKE NOTE OF YOUR 6 or 7-DIGIT CLINIC ACCOUNT NUMBER.
YOUR CLINIC ACCOUNT NUMBER IS:
• Clinic Account number(s) are required for software kit registration.
• One software update kit will be supplied per account number.
• If ordering for more than one clinic, input all applicable account numbers at time of registration.
• Clinic Account numbers are required to confirm installation completion for the Field Action REPLY FORM.
o Field Action REPLY FORMS are to be submitted after installation.
• Customer Service/Technical Service cannot process software upgrade kit orders for this field action.
*If experiencing technical issues trying to access the website, please contact Fresenius Technical Services at 1-800-227-2572, option 4.
Each SW upgrade kit includes:
• Installation instructions
• 2 USB Flash drives
• Field Action REPLY FORM
• Additional product information
Fresenius Medical Care Renal Therapies Group cares about the safety and wellbeing of our patients. We urge you to register and install the Software update. Thank you for continued support and cooperation.
Notification to Biomed: CLiC
DO NOT DISCARD – USE FOR SW INSTALLATION
➢ If your clinic does not use the CLiC Device on its 2008T Hemodialysis Machines, there is no need to perform the steps below.
➢ If your clinic uses the CLiC™ device on its 2008T Hemodialysis Machines, please perform the steps below:
1. After installing the 2.74 software, reboot the 2008T Hemodialysis Machine.
2. Once the 2008T Machine has rebooted, select the Crit-Line Tab at the bottom of the screen and you will see the following screen:
Note: You may or may not see the “Crit-Line need verification” message but you will see the green boundary lines in the display.
3. Push the Boundary Lines option so the green boundary lines are no longer displayed. You will now see the following screen.
Again, you may or may not see the “Crit-Line need verification” message.
4. Turn OFF the 2008T Hemodialysis Machine.
Upon installation, your Software update Kit will include the document; Crit-Line Profile Boundary Guidance: A Clinician’s Guide (P/N 490425 Rev. A). Please share with the Nurse Manager, Clinic Manager or staff member assigned to staff training. NOTE: When the clinical staff are ready to start using the boundary lines, they can simply push the Boundary Lines button on the Crit-Line screen and the boundary guidance lines will appear on the screen.
For additional information, please refer to the following documents: 490122, 2008T Hemodialysis Operator’s Manual, W | 490206, 2008T Hemodialysis Machine with CLiC Device User’s Guide, Rev F.
Corporate Headquarters: 920 Winter Street Waltham, MA 02451 (781) 699-9000
Pg. 1 of 3
IMPORTANT MEDICAL DEVICE CORRECTION
2008T® & 2008T BlueStar™ Machine
Remove USB Device 2 Alarm
Field Action Number: FA-2020-09-W_REV A_Software Now Available
Dear Valued Customer,
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG, LLC) sent you a notification on May 5, 2020 for a potential issue when using the 2008T or 2008T BlueStar hemodialysis machines. A “Remove USB Device 2” false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine. The May 5, 2020 communication indicated this software issue only pertained to CDX™ installed machines. However, this software issue affects all 2008T and 2008T BlueStar machines regardless.
We are pleased to notify you we have developed and are making available a software update Part Number 191137 REV F (software v.2.74) which will address the above situation. This software update is being provided to you at no charge.
This software will also include the additional features: *
• Installing this software update on non 2008T BlueStar machines will upgrade your machines to 2008T BlueStar’s standard software and features. 2008T BlueStar standard software only supports 45X concentrates.
• Crit-Line® Boundary Profile Lines
o See attached Biomed Notification.
• If 2008T BlueStar Premium is currently installed, this software upgrade will allow for a “Rinse” option with your Auto Start feature. This option is only available if you have 2008T BlueStar Premium currently installed.
PLEASE NOTE: Software update v 2.74 Part Number 191137 (REV F) will only support 45X concentrates.
* Please reference 2008T Hemodialysis Operator’s Manual for more information on these and other 2008T BlueStar features. You may download the Operators Manual from the Fresenius Medical Care Support Website: fmcna.com/support/
In order to receive software v 2.74 update:
Please go to the FIELD ACTION REGISTRATION SITE:
Access this site directly: fmc-rtg.force.com/FAUSB2 (link is case sensitive) or via the QR code below:
• PLEASE KEEP THIS NOTIFICATION AND MAKE NOTE OF YOUR 6 or 7-DIGIT CLINIC ACCOUNT NUMBER.
YOUR CLINIC ACCOUNT NUMBER IS:
• Clinic Account number(s) are required for software kit registration.
• One software update kit will be supplied per account number.
• If ordering for more than one clinic, input all applicable account numbers at time of registration.
• Clinic Account numbers are required to confirm installation completion for the Field Action REPLY FORM.
o Field Action REPLY FORMS are to be submitted after installation.
• Customer Service/Technical Service cannot process software upgrade kit orders for this field action.
*If experiencing technical issues trying to access the website, please contact Fresenius Technical Services at 1-800-227-2572, option 4.
Each SW upgrade kit includes:
• Installation instructions
• 2 USB Flash drives
• Field Action REPLY FORM
• Additional product information
Fresenius Medical Care Renal Therapies Group cares about the safety and wellbeing of our patients. We urge you to register and install the Software update. Thank you for continued support and cooperation.
Notification to Biomed: CLiC
DO NOT DISCARD – USE FOR SW INSTALLATION
➢ If your clinic does not use the CLiC Device on its 2008T Hemodialysis Machines, there is no need to perform the steps below.
➢ If your clinic uses the CLiC™ device on its 2008T Hemodialysis Machines, please perform the steps below:
1. After installing the 2.74 software, reboot the 2008T Hemodialysis Machine.
2. Once the 2008T Machine has rebooted, select the Crit-Line Tab at the bottom of the screen and you will see the following screen:
Note: You may or may not see the “Crit-Line need verification” message but you will see the green boundary lines in the display.
3. Push the Boundary Lines option so the green boundary lines are no longer displayed. You will now see the following screen.
Again, you may or may not see the “Crit-Line need verification” message.
4. Turn OFF the 2008T Hemodialysis Machine.
Upon installation, your Software update Kit will include the document; Crit-Line Profile Boundary Guidance: A Clinician’s Guide (P/N 490425 Rev. A). Please share with the Nurse Manager, Clinic Manager or staff member assigned to staff training. NOTE: When the clinical staff are ready to start using the boundary lines, they can simply push the Boundary Lines button on the Crit-Line screen and the boundary guidance lines will appear on the screen.
For additional information, please refer to the following documents: 490122, 2008T Hemodialysis Operator’s Manual, W | 490206, 2008T Hemodialysis Machine with CLiC Device User’s Guide, Rev F.