Anticoagulant Citrate Phosphate Double Dextrose Solution

Dosage form: solution

Instructions for Use

For use with Haemonetics Apheresis Devices
Rx Only

Products: Anticoagulant Citrate Phosphate Double Dextrose (CP2D)
and Additive Solution Formula 3 (AS-3)

Company:
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184

I. Indications for Use

The Haemonetics 250mL Anticoagulant Citrate Phosphate Double Dextrose (CP2D)
and 250mL Additive Solution Formula 3 (AS-3) nutrient solution are intended to be
used only with automated apheresis devices for collecting human blood and blood
components. The anticoagulant solution is metered by the apheresis machine into
the collected whole blood. It is not to be infused directly into the donor. After the
anticoagulant is used, the bag in which it was contained is discarded. When
collecting plasma in the RBCP protocol, the plasma is collected into an empty plasma
collection bag. One hundred milliliters (100ml) of AS-3 is transferred into one RBC
collection bag when using the RBCP protocol or 2 separate bags when using the
2RBC protocol. AS-3 solution provides nutrients to keep the red blood cells viable for
42 days when refrigerated.

CP2D is also indicated for the collection of FFP and PF24 plasma, collected and
stored plasma collected using the 822, 822-2P and 822F-2P disposable sets may be
frozen within 8 hours (FFP) or within 24 hours which includes 8 hours room
temperature storage and 16 hours refrigeration storage (PF24).

The 300mL AS-3 is used in conjunction with automated red blood cell washing
devices. AS-3 serves as the nutrient solution for storage of the red blood cell product
after deglycerolization. The red blood cells are washed using the Model 215 System.
AS-3 is used for priming the disposable and for the last wash of the red blood cells.
The washed cells are then re-suspended in 100mL of the AS-3 before transfer into a
product collection bag or storage bag. Additive Solution Formula 3 (AS-3) provides
nutrients to keep the washed red blood cells viable for up to 14 days after washing
when refrigerated.

Neither the CP2D nor the AS-3 container is used for the storage of blood or blood
components.

Dosage Form

The container for all CP2D and AS-3 solutions is a flexible polyvinyl chloride (PVC)
bag sized for holding the appropriate amount of solution. The bag has a single port
that is used for bag filling. The port is sealed after filling with a male luer assembly
(CP2D) or female luer