Leukotrap WB System – CP2D

LEUKOTRAP WB SYSTEM — CP2D- dextrose solution
LEUKOTRAP WB SYSTEM — AS3- adenine and dextrose solution
Haemonetics Corporation

DESCRIPTION

CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter and Sampling System

Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok Vacuum Tube Holder).

Refer to unit foil package label for specific product description being used.

Sterile, nonpyrogenic fluid path. Sterilized by steam.

Rx only.

This product is free of natural rubber latex.

INDICATIONS AND USAGE

For collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.

WARNINGS

Failure to achieve and maintain a closed system during processing would result in a product that must be transfused within 24 hours.

GENERAL PRECAUTIONS

Use aseptic technique. Use only if solutions are clear. Platelet concentrates are not intended to be made with this product.

During processing, always observe the following precautions:

1. Sealing should be done in a manner that avoids fluid splatter.

2. Always dispose of blood-contaminated products in a manner consistent with established BIOHAZARD safety procedures.

STORAGE

Store CP2D/AS-3 preserved red blood cells at 1—6 °C for up to 42 days and use as indicated.

If AS-3 is not used, whole blood or red blood cells in CP2D alone may be stored at 1—6 °C for up to 21 days.

BLOOD COLLECTION INSTRUCTIONS FOR SYSTEMS CONTAINING A Y SAMPLING SITE (YSS) ONLY

1. Load blood agitation device or suspend blood bag on donor scale and adjust donor scale to desired collection gross weight as per manufacturer’s instructions.

2. Clamp donor tubing between Donor Care ® Needle Guard (DCNG) and Y Sampling Site.

3. Secure donor tubing above the Y connector and disinfect site of phlebotomy.

4. If using blood pressure cuff, inflate to not more than 60 mm Hg.

5. Remove donor needle cover and accomplish phlebotomy.

6. Release clamp and ensure there is blood flow. Reduce pressure as required.

7. Slide the DCNG midway over the needle hub and securely tape DCNG to the donor’s arm as close to the top of the DCNG as possible. Note: If blood flow is slow, slide DCNG away from the needle hub, adjust and re-engage DCNG. If repeated needle adjustment is necessary, slide DCNG away from the needle hub and re-engage at the end of blood collection.

8. Collect appropriate volume of blood into collection bag, as indicated on packaging.

Note: Mix blood and anticoagulant frequently during collection, for example, once every 45 seconds, and immediately after collection. If blood agitation device is used, follow manufacturer’s operating instructions.

9. After required amount of blood has been collected, seal donor tubing between Y Sampling Site and collection bag. Note: If pre-filtration quality control is to be performed, leave an adequate length (~10 inches) of QC tubing containing anticoagulated blood attached to the collection bag.

10. For blood sampling, remove the Y Sampling Site needle cover. Ensure the protective sheath is in place over the sampling needle.

11. Fasten the vacuum tube holder on to the base of the sampling needle.

12. Collect blood samples into vacuum tubes.

13. Ensure the vacuum tubes are centered within the vacuum tube holder.

14. Maintain forward pressure on the vacuum tubes during sample collection. Note: After the last tube is collected, it is recommended that the vacuum tube holder be left in place.

15. After blood samples are collected, clamp donor tubing between the Y Sampling Site and as close to the DCNG as possible.

16. Release any remaining pressure from the donor’s arm.

17. DCNG must be held stationary while the needle is withdrawn into it. While holding sides of DCNG near the front, grasp the tubing below the clamp and pull the needle into the DCNG until it locks into place, and the needle hub engages the bottom of the DCNG.

18. Insert the DCNG into the vacuum tube holder. Note: It is recommended that the DCNG be inserted securely into the vacuum tube holder, prior to discarding.

19. Seal donor tubing adjacent to DCNG. Detach and discard needle, DCNG, Y Sampling Site and tubing.

20. Strip tubing between seal and collection bag.

21. Continue to “Filtration Instructions”, Step 1.

BLOOD COLLECTION INSTRUCTION FOR SYSTEMS CONTAINING A SAMPLE DIVERSION POUCH WITH OR WITHOUT A PRE-ATTACHED SAMP LOK VACUUM TUBE HOLDER

When using systems with a pre-attached Samp Lok vacuum tube holder, follow instructions as noted below, but refer to “When Using Systems with a Pre-attached Samp Lok Vacuum Tube Holder” when indicated to do so.

1. Load blood agitation device or suspend blood bag on donor scale and adjust donor scale to desired collection gross weight as per manufacturer’s instructions.

2. Clamp donor tubing between Donor Care Needle Guard (DCNG) and Sampling Site.

3. Secure donor tubing above the Y connector and disinfect site of phlebotomy.

4. If using blood pressure cuff, inflate to not more than 60 mm Hg.

5. Remove donor needle cover and accomplish phlebotomy.

6. Release clamp and ensure there is blood flow.

7. Slide the DCNG midway over the needle hub and securely tape DCNG to the donor’s arm as close to the top of the DCNG as possible. Note: If blood flow is slow, slide DCNG away from the needle hub, adjust and re-engage DCNG. If repeated needle adjustment is necessary, slide DCNG away from the needle hub and re-engage at the end of blood collection.

8. The donor blood will be automatically diverted to the sample diversion pouch. Once the sample diversion pouch is filled, close clamp immediately on tubing between the sample diversion pouch and Y connector. Warning: To avoid risk of air embolism to donor, do not squeeze sample diversion pouch while tubing is open.

9. Open snap-open closure between the Y connector and the collection bag to initiate blood collection. Reduce pressure as needed.

10. Permanently seal tubing between the sample diversion pouch and the Y connector to maintain sterility of the system prior to collecting blood samples. Note: When using systems with a pre-attached Samp Lok vacuum tube holder, go to “When Using Systems with a Pre-attached Samp Lok Vacuum Tube Holder”.

11. For blood sampling, remove the Sampling Site needle cover. Ensure the protective sheath is in place over the sampling needle.

12. Fasten the vacuum tube holder on to the base of the sampling needle.

13. Position the sample diversion pouch downwards so that the air rises to the top of the pouch and away from the vacuum tube holder. Note: Drawing air into the vacuum tube may cause hemolysis.

14. Collect blood samples from the sample diversion pouch within approximately four minutes to avoid possible clot formation.

15. Ensure the vacuum tubes are centered within the vacuum tube holder during sample collection.

16. Maintain forward pressure on the vacuum tubes during sample collection. Note: After the last tube is collected, it is recommended that the vacuum tube holder be left in place.

17. Collect appropriate volume of blood into collection bag as indicated on packaging.

Note: Mix blood and anticoagulant frequently during collection, for example, once every 45 seconds, and immediately after collection. If blood agitation device is used, follow manufacturer’s operating instructions.

18. After required amount of blood has been collected, seal donor tubing between snap-open closure and collection bag. Note: If pre-filtration quality control is to be performed, leave an adequate length (~10 inches) of QC tubing containing anticoagulated blood attached to the collection bag.

19. Clamp donor tubing between the Y connector and DCNG as close as possible to the DCNG.

20. Release any remaining pressure from donor’s arm.

21. DCNG must be held stationary while the needle is withdrawn into it. While holding sides of DCNG near the front, grasp the tubing below the clamp and pull the needle into the DCNG until it locks into place, and the needle hub engages the bottom of the DCNG.

22. Insert the DCNG into the vacuum tube holder, if desired. Note: It is recommended that the DCNG be inserted securely into the vacuum tube holder, prior to discarding.

23. Seal donor tubing adjacent to DCNG. Detach and discard needle, DCNG, sample diversion pouch and tubing.

24. Strip tubing between seal and collection bag.

25. Continue to “Filtration Instructions”, Step 1.

WHEN USING SYSTEMS WITH A PRE-ATTACHED SAMP LOK VACUUM TUBE HOLDER

1. To collect blood samples, open lid from Samp Lok vacuum tube holder.

2. Open snap-open closure between sample diversion pouch and Samp Lok vacuum tube holder.

3. Position the sample diversion pouch downwards so that the air rises to the top of the pouch and away from the Samp Lok vacuum tube holder. Note: Drawing air into the vacuum tube may cause hemolysis.

4. Collect blood samples from the sample diversion pouch into vacuum tubes within approximately four minutes to avoid possible clot formation.

5. Ensure the vacuum tubes are centered within the Samp Lok vacuum tube holder during sample collection.

6. Maintain forward pressure on the vacuum tubes during sample collection.

7. The lid may be closed on the Samp Lok vacuum tube holder after sample collection.

8. Return to “Blood Collection Instruction for Systems Containing a Sample Diversion Pouch with or without a Pre-attached Samp Lok Vacuum Tube Holder”, Step 17. Note: When collection of unit is complete, and the donor needle is engaged in the DCNG, open the lid of the Samp Lok vacuum tube holder and insert the DCNG into the holder. Twist until it locks into place. An audible click will confirm that it is locked.

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