Data from FDA - Curated by EPG Health - Last updated 30 August 2017


FULL PRESCRIBING INFORMATION *Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17]. 1. INDICATIONS AND USAGE 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 Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 1.6. For further processing, use standard component processing techniques. Image of Figure Sealing with tape Image of Fig. 1 (attach luer adapter to tube holder) Image of Fig. 2 (attach adapter/holder to Blood Sampling Arm)

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Usage information

Dosing and administration
2. DOSAGE AND ADMINISTRATION 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®@Tube Holder (code P-1316R) or equivalent [email protected] 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" 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. Suspend the collection bag as far as possible below the donor's arm. 2.6. 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. 2.7. Remove the needle cover and perform phlebotomy. 2.7.1. CAUTION: Do not touch the needle after removing the needle cover. 2.8. Remove the temporary clamp on the donor tubing to permit blood flow into the collection bag. 2.9. If applicable, secure the needle safety device in place following the device instructions provided on the reverse side. 2.10. Secure donor tubing to donor's arm. 2.11. 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. 2.12. Collect labeled volume of blood 450 mL ±10% or 500 mL ±10%. 2.13. 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. 2.13.1. CAUTION: Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose. 2.14. Anytime before Step # 2.19 below, sever donor tubing between the two seals. 2.15. Assemble the luer adapter and the tube holder. These steps may be performed before or during phlebotomy. 2.15.1. Connect the [email protected] Luer Adapter to the [email protected] Holder (or equivalent) (Fig. 1). 2.15.2. Remove covers and connect the multi-sample luer adapter to the female luer at end of Blood Sampling Arm (Fig. 2). 2.16. Collect blood samples as follows: 2.16.1. Break CLIKTIP® (inline closure device) in the Blood Sampling Arm tubing to open blood pathway. CAUTION: Do not break CLIKTIP until luer adapter/tube holder assembly is attached to the Blood Sampling Arm. 2.16.2. Insert blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples. 2.17. Apply a clamp to the donor tubing between the phlebotomy needle and "Y"; release pressure on donor's arm and remove needle. If using a needle safety device, remove the needle into the needle safety device following the device instructions provided on the reverse side. 2.17.1. CAUTION: Discard the phlebotomy needle/donor tubing according to institutional standard operating procedures. 2.18. Immediately after collection, invert collection bag several times to assure blood and anticoagulant are well mixed. 2.19. 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 Whole Blood unit. 2.20. 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. 2.20.1. If the Whole Blood is to be processed into room temperature components, maintain the blood at ambient temperature. 2.20.2. 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. 2.21. Platelet Rich Plasma and Platelets should be separated from the Red Blood Cells within 8 hours of blood collection, if prepared. 2.22. 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. 2.23. 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. 2.24. For further preparation and processing of other plasma components, use standard processing and storage techniques following approved regulations and standards. 2.25. 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. 2.26. 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. 2.27. Seal tubing of primary collection bag in two places, cut between seals, and if applicable, separate from satellite bag(s). 2.28. Store CPDA-1 Red Blood Cells (or Whole Blood) between 1-6°C for up to 35 days. 2.29. If prepared, store Platelets between 20-24°C, maintaining a continuous gentle agitation, for up to 5 days in XT-612 bag.

More information

Category Value
Authorisation number BN820528
Agency product number XF417D3PSL
Orphan designation No
Product NDC 53877-001
Date Last Revised 24-05-2016
Marketing authorisation holder Terumo Corporation