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Intended Use
The Anticoagulant Connection Adapter is used to connect an apheresis tubing set that has a luer
connector to an anticoagulant solution container that has a spike receptor. The anticoagulant solution
container can be collapsible, such as a bag, or hard-sided, such as a bottle.
Description
The Anticoagulant Connection Adapter is for single use only and includes the following components:
1. AC (anticoagulant) connector with end cap: used to connect to the luer connector on the AC line of a tubing
set
2.
Vent: used when connecting to a hard-sided AC container
3.
Spike with end cap: used to connect to the spike receptor on the AC container
Warnings
1.
This product contains phthalates (DEHP). Whole blood donors are not exposed to DEHP; the
potential health risk to apheresis donors is low, because the time-averaged DEHP dose exposure is
very low. Patient groups that include pregnant or nursing women and children are considered to
be the most at risk to potential harmful effects of exposure to DEHP. However, regulatory bodies
have noted that the benefit of doing a needed procedure is far greater than the risk associated with
exposure to DEHP. It is the responsibility of the treating physician to balance this risk for the
patient.
2.
Do Not Reuse/Not for Reuse: Terumo BCT Inc. products bearing the "Do Not Reuse" symbol
are intended for single use only and are not intended to be reprocessed, reused, or resterilized in
any manner. Terumo BCT cannot ensure the functionality or sterility of the product if it is
reprocessed, reused, or resterilized.
Reuse of a single-use product could result in:
•
Product performance issues due to a loss of product integrity, including but not limited to
the following:
–
Fluid leaks
–
Parts that are warped or deformed
–
Plastics that are brittle and discolored
–
Filters that have reduced filtration capabilities
•
Exposure to excessive ethylene oxide (EtO) residuals
•
Viral infections such as hepatitis or human immunodeficiency virus (HIV)
•
Bacterial infections
•
Cross-contamination
Any of these risks could result in serious injury or death. These risks are shared by product users,
donors, patients, and recipients of end products of the device.
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