Teruflex Blood Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) For Collection Of 450ml Of Blood - Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine solution

1.1. Read these instructions carefully before use.

1.2. Rx ONLY.

1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.

1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.

1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit.

1.6. For further processing, use standard component processing techniques.

2.1. To open blister package, peel cover film back 4/5 of its length.

2.2. Prepare the blood bag following your institution's standard operating procedures.

2.2.1. Materials Needed:

• VENOJECT II Tube Holder (code P-1316R) or equivalent
• VENOJECT II Multi-Sample Luer Adapter (code MN*2000T) or equivalent
• Evacuated blood collection tubes (glass or plastic)

2.3. Make a loose knot in the donor tubing below the "Y" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.

2.4. Temporarily clamp donor tubing between the phlebotomy needle and the "Y".

2.5. Close the White Clamp below the diversion pouch.

2.6. Assemble the luer adapter and the tube holder.

2.6.1. Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig. 1).

2.6.2. Twist and snap to remove the blue port cap at the end of the Diversion Blood Sampling Arm (Fig. 2a).

2.6.3. Insert the Holder/Luer assembly in the female luer port (Fig. 2b).

2.6.4. NOTE: Alternatively, steps 2.6.1., 2.6.2., and 2.6.3. (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.

2.7. Suspend the collection bag as far as possible below the donor's arm.

2.8. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy according to institutional standard operating procedures. If blood pressure cuff is used, inflate to approximately 60 mmHg.

2.9. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.

2.9.1.

2.9.2.

2.10. Secure the needle safety device in place following the device instructions provided on the reverse side.

2.11. Secure donor tubing to donor's arm.

2.12. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in line with the notches, the diversion pouch is full (Fig. 3a).

2.12.1.

2.13. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor (Fig. 3b).

2.13.1.

2.14. To initiate blood flow into the collection bag, break the CLIKTIP between the "Y" and the collection bag.

2.15. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b).

2.15.1.

2.15.2. Open the White Clamp on the tubing below the pouch to open the pathway for sampling.

2.15.3. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly downward. Assure that any air in the pouch is at the top and will not enter the blood collection tubes.

2.15.4. Insert blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.

2.15.5.

2.16. Mix blood with anticoagulant in the collection bag and continue to mix at several intervals during collection and immediately after collection. If using an automated mixer, follow manufacturer's instructions.

2.17. Collect labeled volume of blood 450 mL ±10% or 500 mL ±10%.

2.18. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in Step 2.3. Make a second seal between the first seal or knot and the "Y". Various methods may be used to seal tubing.

2.19. Release pressure on the donor's arm and remove the needle into the needle safety device following the device instructions provided on the reverse side. Sever the donor tubing between the two seals previously made below the CLIKTIP and "Y".

2.19.1.

2.20. Strip blood from donor tubing into collection bag, mix well, and allow tubing to refill; repeat once. To prevent the blood from clotting in the tubing, work quickly as possible. Make an appropriate number of segments of anticoagulated blood for testing by sealing on or near the X marks. Leave segments attached to the Whole Blood unit.

2.21. The time between Whole Blood collection and component separation may vary depending on both the blood bag system and processing options selected. Follow your institution's standard operating procedures to prepare components.

2.21.1. If the Whole Blood is to be processed into room temperature components, maintain the blood at ambient temperature.

2.21.2. If the Whole Blood is to be processed into other components (including Plasma Frozen Within 24 Hours After Phlebotomy), Whole Blood must either be placed in storage at a temperature between 1-6°C within 8 hours of blood collection or cooled towards a temperature between 1-10°C (e.g. during transport) and then placed in storage at a temperature between 1-6°C upon arrival at the processing center.

2.22. Platelet Rich Plasma and Platelets should be separated from the Red Blood Cells within 8 hours of blood collection, if prepared.

2.23. Plasma intended for production of Fresh Frozen Plasma should be separated from the Red Blood Cells and placed in a freezer at –18°C or colder within 8 hours of blood collection.

2.24. Plasma intended for production of Plasma Frozen Within 24 Hours After Phlebotomy (PF24) should be placed in a freezer at -18°C or colder within 24 hours of blood collection.

2.25. For further preparation and processing of other plasma components, use standard processing and storage techniques following approved regulations and standards.

2.26. Select the appropriate spin condition and centrifuge Whole Blood unit to separate CPDA-1 Red Blood Cells from plasma or platelet rich plasma, as appropriate.

2.27. Break the CLIKTIP of primary collection bag and transfer plasma into satellite bag, or transfer platelet rich plasma into XT-612 Platelet bag. Clamp transfer tubing of satellite bag.

2.28. Seal tubing of primary collection bag in two places, cut between seals, and if applicable, separate from satellite bag(s).

2.29. Store CPDA-1 Red Blood Cells (or Whole Blood) between 1 – 6°C for up to 35 days.

2.30. If prepared, store Platelets between 20-24°C, maintaining a continuous gentle agitation, for up to 5 days in XT-612 bag.

3.1. 63 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant USP for collection of 450 mL Whole Blood. Each 63 mL contains 188 mg Citric Acid (anhydrous) USP, 1.66 g Sodium Citrate (dihydrate) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP, 2.01 g Dextrose (monohydrate) USP and 17.3 mg Adenine USP.

3.2. 70 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant USP for collection of 500 mL Whole Blood. Each 70 mL contains 209 mg Citric Acid (anhydrous) USP, 1.84 g Sodium Citrate (dihydrate) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, 2.23 g Dextrose (monohydrate) USP and 19.3 mg Adenine USP.

11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL).

11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit.

11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side.

11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer).

11.5. The blood bag has no components made of natural rubber latex.

11.6. Tubing internal diameter (ID) nominal 3.0 mm.

11.7. Tubing outer diameter (OD) nominal 4.4 mm.

11.8. Donor tubing line maximum 16 segments available.

16.1. Single use only.

16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

16.3. A Material Safety Data Sheet (MSDS) is not required for this product.