here is the bulletin Fresenius sent out.......
Dear Valued Customer,
The purpose of this notification is to inform you that Fresenius Medical Care Renal Therapies Group,
LLC (FMCRTG, LLC) has discovered 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 po1i on the rear of the machine. To
clear the alarm, tum the machine power off for 30 to 45 seconds and turn back on. If the alarm has not
been cleared, repeat the power off cycle again. If still not cleared, perform a manual blood return and
remove the patient from the machine. Remove the machine from service and contact a qualified
service technician. This alarm may reoccur even after a power cycle has been performed.
A true alarm will only occur when an externally powered USB device is connected. Refer to the
Operators Manual Troubleshooting section for instructions.
In rare instances, underdialysis, hypertension, and hypervolemia may occur as a result of an
interrupted treatment. Symptoms may include fatigue, weakness, nausea, headache, etc., which
typically resolve with resuming the treatment or at the next treatment with an appropriate
prescription.
A software solution is being created that addresses this situation. Once the software upgrade is
available, an additional notification will be sent with instructions on how to order the upgrade at no
charge.
If you experience this issue or have additional questions, please contact Fresenius Medical Care
Technical Services at 800-227-2572.
We apologize for any inconvenience this may cause. We thank you for your cooperation and timely
response to the enclosed reply form.
