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Leukotrap CP2D Solution
  • Professionals
  • FDA PI

Leukotrap CP2D Solution

Dosage form: solution

LEUKOTRAP® RC SYSTEM DESCRIPTION

The Leukotrap® RC System CP2D/AS-3 Blood Bag Unit with In-Line RC2D Filter and Sampling System is intended for the collection of whole blood and preparation of red blood cells and plasma or red blood cells, plasma, and platelets with pre-storage leukocyte reduction of red blood cells. The fluid pathway is sterile and non-pyrogenic. Steam Sterilized. RX only.

Indications and Usage for Leukotrap CP2D Solution

Instructions for Use for Systems Containing a Y Sampling Site (YSS) with or without a pre-attached Vacuum Tube Holder or Sample Diversion Pouch (SDP) with a pre-attached Vacuum Tube Holder. See unit foil envelope for specific product code/description being used.

Figure 1- Diagram of the Complete Product Set

I. BLOOD COLLECTION INSTRUCTIONS FORSYSTEMS CONTAINING A Y SAMPLING SITE (YSS) ONLY

Figure 2- Donor Line with Y Sampling Site Only

ACCOMPLISHING PHLEBOTOMY
1.
Load blood collection mixer or suspend blood bag on donor scale. Adjust to desired collection volume or weight as per operating instructions for whichever equipment is being used. Place collection bag on blood collection mixer or donor scale as far below donor arm as possible.
2.
If not previously performed, place a temporary clamp on the donor tubing between the donor needle and Y-connector.
3.
Disinfect site of phlebotomy and apply pressure to donor arm. If using a blood pressure cuff, inflate to not more than 60 mm Hg. If desired, secure the tubing to the donor’s arm with tape below Phlebotomist Protection Device (PPD). Note:Steps 1 through 3 can be performed in any order.
4.
Remove donor needle cover by first twisting the cover at the base to break the seal, and then remove cover carefully.
5.
Perform phlebotomy. Remove the temporary clamp, if used, and ensure there is blood flow.
6.
Stabilize the donor needle with tape.
7.
If not previously performed, further stabilize the donor needle by taping the tubing below the PPD.
8.
Reduce pressure on donor’s arm as needed.
COLLECTING BLOOD
1.
Collect appropriate volume of blood into collection bag, as indicated on packaging. Notes: If blood c...