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| CPD/ADSOL [Fenwal, Inc.] | BioPortfolio

13:40 EST 27th January 2019 | BioPortfolio

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Rx only

Contains Y-Sampling Site for the collection of unanticoagulated whole blood samples for laboratory testing and the DONORCARE Needle Guard.

Integral filter unit intended for leukocyte reduction of AS-1 red blood cells:

The leukocyte reduced red blood cells may then be stored for the maximum allowable dating period.

Instructions for Use

Collection Procedure:

Use aseptic technique.

Note: Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness.

Note: If the Y-Sampling Site is not used, donor samples may be collected using an alternate method following standard procedures.  Precautions:

• Do not use unless the solutions are clear.

• Before beginning procedure, obtain one access device for each BLOOD-PACK unit with Y-Sampling Site to be processed.

1. Identify BLOOD-PACK unit using appropriate donor identification system. 2. Adjust donor scale to desired collection weight and position primary container on the donor scale as far as possible below donor arm. 3. Clamp donor tubing between needle and primary container. This step may be performed prior to step 1 or 2. 4. Apply pressure to donor’s arm and disinfect site of venipuncture. 5. If blood pressure cuff is used, inflate to approximately 60 mmHg. 6. Remove needle cover per instructions below: a) Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal. b) Remove needle cover, being careful not to drag the cover across the needle point. 7. Perform venipuncture, appropriately secure donor needle and/or tubing and release clamp on donor tubing. 8. When good blood flow is established, slide the DONORCARE needle guard over the needle hub into the engaged position. Leave the front third of the needle hub exposed for access. Stabilize the front of the needle guard to arm with tape (see Figure 1). Note: In difficult collection conditions (e.g., slow blood flow), leave the needle guard disengaged behind the hub during collection. Engage the needle guard at the end of blood collection. 9. Mix blood and anticoagulant in primary container at several intervals during collection and immediately after collection. 10. Collect the appropriate volume based on BLOOD-PACK unit used. Note: The volume of anticoagulant is sufficient for the blood collection indicated on BLOOD-PACK unit ± 10%. 11. Release the pressure on the donor’s arm as appropriate. Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected. 12. To avoid possible contamination of the whole blood unit, before filling whole blood sample tubes, hermetically seal the donor tubing near the Y-Sampling Site on the side leading to the primary container using a metal clip or appropriate alternate method. Precaution: Complete steps 13 - 22 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing. 13. To collect samples, insert the access device by pushing firmly into the Y-Sampling Site until the membrane seal is penetrated (see Figure 2). Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer. 14. Open the cap on the access device (if applicable). 15. Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device until the stopper is punctured. 16. Allow vacuum sample tube to fill with blood then remove from the access device. 17. Repeat steps 15 and 16 until the desired number of vacuum sample tubes have been filled. Notes: • If the access device needs to be replaced, use a hemostat to clamp the tubing between the needle and the Y-Sampling Site. Then, grasp base of Sampling Site with one hand and pull the access device out with the other hand. Firmly insert the new access device. Remove hemostat and continue sampling. • If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon removal to avoid barrel detaching from Luer. • The access device can only be replaced one time. Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately. 18. Release remaining pressure on donor's arm. 19. If desired, apply hemostat to donor tubing between needle and Y-Sampling Site. 20. Withdrawal of Needle (see Figure 3) Precaution: The needle guard must be held stationary while the needle is withdrawn into it. a) Place folded sterile gauze over puncture site and hold in place with finger tip without exerting pressure. b) Hold sides of needle guard near the front, between the index finger and thumb. Pull the tubing smoothly until the needle is locked into the needle guard. c) Confirm the needle lock by: • Listen for the 2nd “click” as the needle is drawn into the needle guard. • Ensure the tubing cannot be pulled through the needle guard. 21. Remove and discard the Y-Sampling Site and needle guard into an appropriate biohazardous waste container following established procedures. If donor tubing is also to be discarded, hermetically seal donor tubing directly above the primary container and remove. Note: Step 22 may be performed prior to step 21 if desired. 22. If the donor tubing is not hermetically sealed directly above the primary container, then strip the blood from the remaining donor tubing into the primary container. Mix and allow tubing to refill; repeat once. Component Preparation: Notes: • If a platelet concentrate is to be prepared, it should be separated within 8 hours after blood collection. • Fresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18°C or colder within 8 hours after blood collection. • ADSOL™ red cell preservation solution should be added to the red blood cells immediately after the removal of plasma. Preparation of AS-1 red blood cells may vary depending on processing option selected: a) Within 8 hours of blood collection if whole blood is held at ambient temperature. b) Within 3 days of blood collection if whole blood is refrigerated. 23. At the appropriate time, prepare the BLOOD-PACK unit with Integral Filter for centrifugation. 24. Thoroughly mix the primary container end over end. 25. Load the BLOOD-PACK Unit into a centrifuge cup per the instructions on page 3 or 4. Page 3 describes Option A, the coil tubing method of cup loading. Page 4 describes Option B, the drop tubing method of cup loading. Notes: • This guide is one method for centrifuge cup loading and applies to all Flex-Excel configurations. The specific stacking order and methods may vary depending on the workstation setup, centrifuge equipment, and Standard Operating Procedures. • It is important to pack the filter properly in the centrifugation cup to avoid damage to the filter during centrifugation. • Check valve must be placed in a horizontal position (Figure 4a, page 2). Avoid the clear (red tip) side from pointing downward (Figure 4b, page 2). See step 3 on page 3 or 4. • Do not place the filter, breakaway cannula or check valve in the lower half of the centrifuge cup. See step 5 on page 3 or 4. 26. After loading the BLOOD-PACK Unit into the centrifuge cup, perform centrifugation according to center procedures. 27. Following centrifugation, remove containers from the centrifuge cup taking care not to disturb the red blood cell / plasma interface. 28. Place primary container in a plasma extractor and apply pressure. Open the cannula on the top of the primary container to transfer plasma into the empty TRANSFER-PACK™ container. 29. When the desired amount of plasma has been removed, clamp the tubing between the plasma container and the Y-connector closest to the plasma container and release pressure on the primary container. 30. Suspend the ADSOL red cell preservation solution container, open the cannula on the ADSOL solution container and drain the contents into the primary container of the CPD red blood cells. Clamp the ADSOL red cell preservation solution tubing. 31. Hermetically seal and separate the tubing between the Y-connectors or above the plasma TRANSFER-PACK™ container. Be careful to avoid fluid splatter. 32. Mix the ADSOL red cell preservation solution and red cells thoroughly. Note: If the ADSOL red cell preservation solution is not added to the red cells, ensure appropriate labeling of the red cell container. The pre-filter container does not include tubing with segment numbers. A CPD red cell without ADSOL red cell preservation solution may be stored between 1 and 6ºC up to 21 days after collection. The attached SEPACELL™ FLEX-EXCEL™ filter should not be used to leukoreduce a CPD red cell without ADSOL red cell preservation solution. Filtration Procedure: Precaution: Red blood cell products collected from certain donors may have extended filtration times and the potential for ineffective filtration and leukoreduction. 33. Mix unfiltered AS-1 red blood cells thoroughly. Invert the unfiltered AS-1 red blood cells and hang the filter set such that the filter remains vertical. To achieve maximum flow rate, allow the set to hang to full length. Note: The storage container must remain below the level of the filter during filtration. 34. Inspect all tubing to ensure it hangs freely without kinks. If desired, a temporary clamp may be placed on the vent line, but must be removed prior to expelling air through the vent line. 35. Break the in-line cannula above the filter to start filtration. Note: Manual or mechanical pressure should not be used to increase the flow rate through the filter. Note: Tubing below the filter should not be stripped at any time during the filtration process. Note: If filtration of red cells is initiated at ambient temperature, the filtration process can be completed at either ambient or refrigerated temperature prior to storing the red cells between 1 and 6°C. However, for optimal filtration time, it is recommended to complete the filtration at ambient temperature. 36. As the filtered red cell storage container is filling, or when flow stops, clamp or pinch the tubing below the filter to occlude flow. Note: While the check valve is designed to prevent blood flow from entering the vent line below the valve, blood may flow down and fill the valve. 37. Squeeze the filtered red cell storage container to expel air from the filtered red cell container through the vent line. Continue squeezing the filtered red cell container until the vent line segments and check valve are filled with blood as desired. 38. Remove the clamp or release the tubing below the filter to resume red cell flow through the filter. If desired, the temporary clamp may be replaced on the vent line immediately after removing the clamp below the filter. When filtration is complete, air can be observed in the inlet side of the filter. Note: While the check valve is designed to prevent blood flow from entering the vent line below the valve, it is normal for air to pass through the valve and enter the vent line tubing. To avoid air from entering the vent line below the valve, the vent line may be clamped during this step, or blood may be expressed beyond the check valve during the air expel operation. 39. Hermetically seal and detach the tubing below the filter. Also, hermetically seal and detach the vent line between the one way valve and the top donor segment number. 40. Make segments from the vent line tubing and leave segments attached to the filtered red cell storage container. (QC samples may be prepared by thoroughly mixing the filtered red cells and stripping this tubing prior to sealing the segments.) 41. Store the AS-1 red blood cells, leukocytes reduced between 1 and 6°C. 42. Infuse the red cells within 42 days of collection. Warning: Failure to achieve closed system processing conditions negates the extended storage claim and the red blood cell product must be transfused within 24 hours.

Store at Controlled Room Temperature. USP Definition of "Controlled Room Temperature" United States Pharmacopeia, General Notices. United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville, MD

Fenwal, Inc. Lake Zurich, IL 60047 USA

Made in USA

1-800-933-6925

Manufacturer

FENWAL, BLOOD-PACK, TRANSFER-PACK, ADSOL, and FLEX-EXCEL are trademarks of Fenwal, Inc.

SEPACELL is a trademark of Asahi Kasei Medical Co., Ltd.

DONORCARE is a trademark of ITL Corporation.

© 2018 Fenwal, Inc. All rights reserved. 07-19-13-105    REV: A

Code 4R1582

10 Units

Fenwal™

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit; TRANSFER-PACK™ Container with ADSOL™ Red Cell Preservation Solution; Integral SEPACELL™ FLEX-EXCEL™ Red Cell Leukocyte Reduction Filter

Double For the Collection and Processing of 500 mL Blood

Y-Sampling Site, DONORCARE™ Needle Guard, 16 ga. Ultra Thin Wall Needle

Rx only

Each unit consists of a PL 146 plastic primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 146 plastic satellite container with 110 mL of ADSOL™ red cell preservation solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL PL 2209 plastic TRANSFER-PACK™ container; one integral SEPACELL™ FLEX-EXCEL™ red cell leukocyte reduction filter and one empty 450 mL PL 2209 plastic TRANSFER-PACK container for the storage of AS-1 red blood cells, leukocytes reduced.

Sterile, non-pyrogenic fluid path

See instructions for use.

Store at Controlled Room Temperature (refer to direction insert).

I)Units are not removed from foil pouch, or

II)Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once.

FENWAL, BLOOD-PACK, ADSOL, TRANSFER-PACK and FLEX-EXCEL are trademarks of Fenwal, Inc.

SEPACELL is a trademark of Asahi Kasei Medical Co., Ltd.

DONORCARE is a trademark of ITL Corporation.

Fenwal, Inc. Lake Zurich, IL 60047 USA

Made in USA

07-28-07-173 REV: A

Manufacturer

Fenwal, Inc.

Active Ingredients

Source

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Clinical Trials [0 Results]

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