Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine
FDA Drug Information • Also known as: Teruflex Blood Anticoagulant Citrate Phosphate Dextrose Adenine (Cpda-1) For Collection Of 450Ml Of...
- Brand Names
- Teruflex Blood Anticoagulant Citrate Phosphate Dextrose Adenine (Cpda-1) For Collection Of 450Ml Of Blood, Teruflex Blood Bag System With Diversion Blood Sampling Arm 70 Ml Cpda-1, Teruflex Blood With Diversion Blood Sampling Arm 70 Ml Cpda-1
- Drug Class
- Calculi Dissolution Agent [EPC], Anti-coagulant [EPC]
- Route
- INTRAVENOUS
- Dosage Form
- SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11. DESCRIPTION / PRODUCT SPECIFICATIONS 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.
What Is Anhydrous Citric Acid, Trisodium Citrate Dihydrate, Sodium Phosphate, Monobasic, Monohydrate, Dextrose Monohydrate, And Adenine Used For?
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 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.
Dosage 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 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. CAUTION: Do not touch the needle after removing the needle cover. 2.9.2. CAUTION: Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy. 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. NOTE: The approximate fill volume of the pouch at the notches is 35 mL. 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. 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. 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. CAUTION: Do not collect donor test samples until the tubing between the "Y" and the...
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING 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. 16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). 16.5. Avoid excessive heat and direct sunlight. Protect from freezing. 16.6. To open blister package, peel cover film back 4/5 of its length. 16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions. 16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging. 16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care. 16.10. Dispose of the AGELESS packet with the blister tray. 16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials. 16.12. For the Triple blood bag sets, Codes BB * TCD456A2 and BB * TCD506A2 are supplied 30/case. 16.13. For the Quadruple blood bag sets, Codes BB * QCD456A2 and BB * QCD506A2 are supplied 24/case. MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN MADE IN JAPAN © TERUMO CORPORATION Mar. 2021 All brand names are trademarks or registered trademarks of TERUMO CORPORATION and their respective owners. Figure
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
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