Home > Drugs A-Z > IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative

IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative (Terumo Corporation)

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KIT 15 BAG in 1 CASE (53877-007-41) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG Label Information

Complete IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Information

  • INDICATIONS & USAGE

    Issued 06/06
    N-SP-OP-A-DB 1

    IMUFLEX® WB-SP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (SAVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTION

    Read these instructions carefully before use. Rx ONLY.
    Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature. Preparation of leukocyte reduced red blood cells, plasma, and platelet units may be accomplished with this set. The leukocyte reduced blood components may then be
    stored for the maximum allowable dating period as indicated in the section INSTRUCTIONS FOR COMPONENT SEPARATION.

    For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam.
    Intended for the collection, processing and preservation of human blood and components.

    PRECAUTIONS
    Do not use unless the solutions are clear.
    Avoid excessive heat and direct sunlight. Protect from freezing.
    Recommended storage conditions: Room Temperature (15-30°C/59-86°F).
    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.

    INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique
    (See Fig. 1,Fig. 2a and Fig. 2b )
    Materials Needed: Evacuated Blood Collection Tubes

    1. Prepare the blood bag following your institution's standard operating procedures.
    2. 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.
    3. Temporarily clamp the donor tubing between the phlebotomy needle and the "Y".

    Insert Fig. 1 here

    Image of Fig. 1 (DBSA IMUFLEX WBSP)


    4. Suspend the collection bag as far as possible below the donor's arm.
    5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.
    6. 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.
    CAUTION Do not touch the needle after removing the needle protector.
    7. Secure the needle safety device in place following the manufacturer's instructions.
    8. Secure donor tubing to donor's arm.
    9. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. When the level of blood in the pouch is approximately in line
    with the notches, the diversion pouch is full. (Fig. 2a)
    NOTE: The approximate fill volume of the pouch at the notches is 35 mL.
    10. 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. 2b)
    11. To initiate blood flow into the collection bag, break the CLlKTIP between the "Y" and the collection bag.
    12. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 2b)
    CAUTION
    Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed.
    a) Break the CLIKTIP in the tubing below the pouch to open the pathway for sampling. (Fig. 2b)
    b) 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.
    c) Open the Tube Holder lid and insert blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.
    NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent seal
    prior to removing the pouch.

    Insert Fig. 2a and 2b here
    Image of Fig. 2 (filling DBSA IMUFLEX WBSP)



    13. 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.
    14. Collect labeled volume of blood (±10%).
    15. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot and
    the CLlKTIP below the "Y". Various methods may be used to seal tubing.
    16. Release pressure on the donor's arm and remove the needle into the needle safety device following the manufacturer's instructions. Sever the donor tubing between the two seals
    previously made below the CLlKTIP and "Y".

    CAUTIONDiscard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.
    17. Seal and remove donor tubing from collection bag or strip donor tubing as follows:
    a) To obtain a quality control prefiltration sample, strip blood from donor tubing into collection bag, mix well, and allow tubing to refill; repeat once. Leave an adequate length of tubing
    containing the well-mixed anticoagulated whole blood attached to the collection bag.
    OR
    b) To maximize collection recovery, strip the tubing, mix well and seal tubing close to the collection bag without refilling. Remove tubing from collection bag.


    INSTRUCTIONS FOR BLOOD FILTRATION
    (See Fig. 3)
    NOTE: Wait 1 hour after collection before filtering. Filtration can be accomplished when blood is stored at room temperature for up to eight hours after collection. Remove the tube guides (not depicted) from the coiled tubing prior to filtration.

    Insert Fig. 3 here

    Image of Fig. 3 (IMUFLEX WBSP)


    1. Mix the unfiltered whole blood unit by inverting the collection bag #1 several times.
    2. Hang the collection bag #1, and extend the filtration set to 85 + or - 2.5 cm or 33.5 + or - 1 inch. Verify that the filter is vertical and ensure all tubing is freely suspended. Position and support bags #2-4 on a flat surface (Fig. 4).
    Note: This distance is measured from the outlet of the collection bag to the position of the supported bags as indicated in Fig. 4.
    Verify tubing has been removed from the tube guides and extends freely.

    Insert Fig. 4 here

    Image of Fig. 4 (IMUFLEX WBSP)


    3. Break the CLlKTIP at the outlet of the collection bag #1 and start filtration.
    CAUTIONDo not squeeze the collection bag during filtration. Do not squeeze or apply pressure on the filter while it is attached to the bag containing the filtered blood. If for any reason whole blood passes through the one-way valve, stop filtration immediately and consider the product as non-leukocyte reduced.
    4. Filtration ends when the collection bag is empty or blood flow has stopped. Close the WHITE clamp above the filter.
    5. Expel air through the bypass line and back into the empty collection bag #1 by holding the primary bag #2 upright so that the air will be closest to the ports. Gently squeeze the primary bag containing the leukoreduced whole blood until filtered blood reaches the "Y" below the filter.
    6. Open the WHITE clamp.
    7. Recovery of filtered Whole Blood is complete when the collection bag and the inlet side of the filter have drained or blood flow has stopped. Close the WHITE clamp.
    8. Seal the tubing as close as possible to the "Y" below the filter and properly dispose of the filter and collection bag #1.
    9. Strip the post filter tubing into the primary bag #2, mix well, and allow tubing to refill; repeat once. Make an appropriate number of segments necessary for testing by sealing on or near
    the X marks. Leave segments attached to the filtered whole blood unit.

    INSTRUCTIONS FOR COMPONENT SEPARATION

    NOTE:
    Platelets should be separated from the Red Blood Cells within 8 hours of blood collection.
    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 collection.
    OPTISOL should be added to the Red Blood Cells immediately after removal of the plasma. If plasma is not separated from the Red Blood Cells within 8 hours, OPTISOL
    may be added within 72 hours of collection if Whole Blood is refrigerated.
    Other plasma components may be prepared following approved regulations and standards.

    1. Follow your institution's standard component processing procedures to prepare components.
    2. Centrifuge flltered whole blood unit to separate red blood cells from platelet rich plasma.
    3. Break the CLlKTIP of primary bag #2 and transfer leukocytes-reduced platelet rich plasma into XT-612 Platelet bag #3. Clamp the transfer tubing on the Platelet bag.
    4. Break the CLlKT1P of OPTlSOL Solution bag #4 and drain contents into primary bag #2 containing red blood cells. Seal tubing of primary bag in two places, and cut between seals
    and separate from Platelet and OPTISOL bags.
    NOTE: Empty OPTISOL bag is used for further component preparation.
    5. Invert the red blood cell- OPTISOL mixture several times to insure the final product is well suspended.
    6. Store AS-5 Red Blood Cells, Leukocytes Reduced between 1-6°C for up to 42 days.
    NOTE: Whole Blood or Red Blood Cells in CPD may be stored for up to 21 days at 1-6°C.
    Store Platelets, Leukocytes Reduced between 20-24°C for up to 5 days

    BLISTER PACKAGE
    (See Fig. 5)
    To open blister package, peel the cover film back four fifths of its length. After opening, the blood bag system may be stored at room temperature for 7 days, or it may be stored for for 30 days in the blister package after returning the cover film to the original position and
    sealing with tape to prevent possible loss of moisture.

    Insert Fig. 5 here

    Image of Fig. 5 (Sealing with Tape)

    CAUTIONS
    The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.
    Dispose of the AGELESS packet with the blister tray.
    Do not dispose with wastes containing volatile or flammable materials.

    TERUMO® MANUFACTURED BY: TERUMO CORPORATION44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN
    ®: Registered Trademark © TERUMO CORPORATION 2006 06F20
  • PRINCIPAL DISPLAY PANEL



    Tray/Case Label

    IMUFLEX® WB-SP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE
    BLOOD LEUKOCYTE REDUCTION FILTER (SAVING PLATELETS) WITH DIVERSION
    BLOOD SAMPLING ARM®


    CPD WITH OPTISOL® RED CELL PRESERVATIVE SOLUTION
    FOR COLLECTION OF 500mL OF BLOOD


    Each unit consists of a collection bag containing 70mL of Anticoagulant
    CPD solution, with a satellite bag containing 111mL of OPTlSOL Red
    Cell Preservative Solution.
    Each 70mL Anticoagulant CPD solution USP contains 1.79g Dextrose
    (monohydrate) USP, 1.84g Sodium Citrate (dihydrate) USP, 209mg Citric
    Acid (anhydrous) USP, 156mg Monobasic Sodium Phosphate
    (monohydrate) USP.
    Each 111mL OPTISOL Red Cell Preservative Solution contains 974mg
    Sodium Chloride USP, 1.00g Dextrose (monohydrate) USP, 583mg
    Mannitol USP, 33.3mg Adenine USP.
    STERILE, NON-PYROGENIC FLUID PATH.
    DO NOT USE UNLESS SOLUTIONS ARE CLEAR.


    CODE

    LOT No.

    EXPIRY

    UNIT(S)

    DONOR NEEDLE 16G x 1 1/2˝ (1.60 x 38mm)

    Rx ONLY

    RECOMMENDED STORAGE: Room Temperature (15-30°C/59-86°F).
    Avoid excessive heat. Protect from freezing.

    After opening, the blood bag system may be stored at room temperature for 7 days, or it may be stored for 30 days in the blister package after returning the cover film to the original
    position and sealing with tape to prevent possible loss of moisture.
    See Instructions For Use.

    Manufactured by : TERUMO CORPORATION Tokyo, Japan
    ® : Registered Trademark

    Issued 01/06
    B-4-HS6-A2 1
    Place Label here
    IMUFLEX WB-SP Blister-Case label text





  • INGREDIENTS AND APPEARANCE
    IMUFLEX WB-SP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (SAVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE 
    anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53877-007
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53877-007-41 15 in 1 CASE
    1 1 in 1 BAG
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BAG 70 mL
    Part 2 1 BAG 111 mL
    Part 1 of 2
    ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)  
    anticoagulant citrate phosphate dextrose (cpd) solution
    Product Information
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Trisodium Citrate Dihydrate (UNII: B22547B95K) (Citric Acid - UNII:2968PHW8QP) Trisodium Citrate Dihydrate 26.3 g  in 1000 mL
    Sodium Phosphate, Monobasic (UNII: 3980JIH2SW) (Phosphoric Acid - UNII:E4GA8884NN) Sodium Phosphate, Monobasic 2.22 g  in 1000 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (Dextrose - UNII:IY9XDZ35W2) Dextrose Monohydrate 25.5 g  in 1000 mL
    Anhydrous Citric Acid (UNII: XF417D3PSL) (Citric Acid - UNII:2968PHW8QP) Anhydrous Citric Acid 2.99 g  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 70 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA880217 02/26/2010
    Part 2 of 2
    OPTISOL RED CELL PRESERVATIVE  
    as-5 red cell preservative solution
    Product Information
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 877 mg  in 100 mL
    Dextrose Monohydrate (UNII: LX22YL083G) (Dextrose - UNII:IY9XDZ35W2) Dextrose Monohydrate 900 mg  in 100 mL
    Mannitol (UNII: 3OWL53L36A) (Mannitol - UNII:3OWL53L36A) Mannitol 525 mg  in 100 mL
    Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161) Adenine 30 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 111 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA880217 12/15/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA880217 12/15/2010
    Labeler - Terumo Corporation (690543319)
    Establishment
    Name Address ID/FEI Business Operations
    Terumo Corp. - Fujinomiya Factory 695214015 manufacture