Info from NxStage

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Customer Communication

April 7, 2008

Dialysate Bag Hanging Holes Changed
Can I Use Dialysate Bags that were Frozen?
New Material for Priming Spike
Examining for Kinks
Cartridge Overwrap is Not a Sterile Barrier
Internet Connectivity is a Good Option for Logfile Download
New Warmer Disposable Labeling and Packaging
New CAR-124 Tray

Dialysate Bag Hanging Holes Changed

Several months ago we sent out a Customer Communication announcing that the
bag design on our dialysate had changed, including the removal of the bag center
hole. While our labeling has always instructed users to hang the bags using two
holes instead of just one for safety reasons, we have had numerous calls into Tech
Support with reports of 38 alarms and wasted dialysate because hanging the new
bags with only one hole forces the bag to hang at an angle with the port no longer
the bottommost point. It is important, therefore, to remind your patients to use both
holes to hang the new bag.

We have also had reports that the new design is more difficult to hang. Many report
that the holes are not punched out when received and that when they are, they are
more difficult to hang on the IV pole. As a result, we have instituted two new
procedures at our dialysate vendor—one to ensure our supplier fully cuts and
vacates the holes, and two, to enlarge the hole diameter by 2-3mm. Patients should
start to see these changes in the product within a few months.

Can I Use Dialysate Bags that were Frozen?

In recent winter months, we have had a number of patients call in concerned that
their dialysate bags were frozen during transit. The IFU enclosed with the dialysate
bags indicates that the bags should be stored at room temperature. Freezing should
be avoided as the bag material can crack when frozen causing the dialysate to leak
out. However, if the bag is intact after thawing, the dialysate is safe to use. The
attached letter explaining this can be distributed to any patient or center wishing
further documentation on this practice.

New Material for Priming Spike

We have recently been notified by a number of our customers that the saline bag
design sold by Fresenius has changed. These changes appear to include a longer
port section and a tougher diaphragm within the port making them more difficult
to spike. If the spike is not fully inserted into the port, saline may not be
successfully drawn through the cartridge during prime, causing multiple 38 alarms.

We are in process of qualifying a harder, more structurally rigid material for our
spikes. We expect that this solution is a few months away, however. In the
meantime, please apply additional force while inserting the spike to be sure the
saline outlet is flush with the disc on the priming spike.

Examining for Kinks

As part of our continuous improvement process, we continue to work to minimize
kinking in cartridge lines. We now coil the patient lines on top of the cartridge in a
very specific manner to prevent any clamps or luers from being coiled on sensitive
areas of the cartridge or on the lines themselves. We also ensure that the coils are
placed on the tray so as to prevent overlap that could cause the line to become
compressed against the walls of the box. Finally, we vent the outer plastic
overwrap on the cartridge to prevent excessive vacuum sealing, which was at
times, flattening the patient lines.

Patients are seeing the results of these actions currently, and we hear that kinks
have declined. However, some patients have become so sensitive to looking for
kinks, they are rejecting cartridges if there is even the slightest out-of-round
condition on a line. To assist our patients in determining whether to reject a
cartridge or not, we are providing the following definition of a kink, which
Medisystems has been using for many years. Any tubing that is occluded by a
kink more than 35% of its original outer diameter should be rejected, particularly
if found on a blood line. In this case, the patient should notify Technical Support
with the complaint and use a different cartridge for treatment.

Cartridge Overwrap is Not a Sterile Barrier

Technical Support has received a number of calls from our patients with
comments indicating that they believe the plastic overwrap cartridge bags provide
a sterile barrier around the cartridge. Patients should be reminded that it is the
fluid pathway that is sterile and if any part of the cartridge is received
disconnected, such as a luer connection or the priming spike cap, they should
contact Technical Support with the complaint and use a different cartridge for
treatment.

Internet Connectivity is a Good Option for Logfile Download

This is just a reminder that patients who have their house networked for cable
internet access can opt to connect their Cyclers for logfile extraction to a regular
CAT5/Ethernet connection instead of the phone line. This will permit transfer of
data files without interfering with phone service at any time. It is also a good
option for those patients without landline phones.

New Warmer Disposable Labeling and Packaging

Due to the number of packages of warmer disposable sets that are lost in transit,
we will be shipping FWS-206 and FWS-209 product soon in larger boxes
measuring 13” x 11.5” x 8”. Each box will contain 24 individually wrapped
disposable sets and a single IFU. Labels on these boxes will have a “-B” suffix,
such as FWS-206-B. All patients will receive a case at start up as part of their
reserves. Bagged patients will be shipped one case per month with their other
supplies. PureFlow SL patients can reorder if their reserves get low over time.
New centers will also receive a case at start up. Patients will begin to receive these
new cases within the next two to three months.

Also going into effect shortly will be new luggage tag-type labels on the warmer
disposable bags. These labels will contain the catalog number, lot number, and
expiry date information for easy identification.

New CAR-124 Tray

Our CAR-124-B filter-less cartridge design has now been transitioned to the new
lighter weight tray used in all our other cartridges. These new cartridges are
labeled CAR-124-C and are being shipped now. Also changed temporarily are the
colors of the filter connectors which will appear a lighter, more translucent color
as a result of our supplier’s company-wide reduction of dye policy. We are in
process of manufacturing custom colored connectors to return the appearance
back to the original colors, but in the meantime, our CAR-124-Cs will have the
lighter colored connectors.