PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE/LABEL DISPLAY PANEL. Code 4R330112 UnitsFenwal(TM)Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack(TM) Unit; Integral Sepacell RS-2000 Whole Blood Leukocyte Reduction FilterDouble For Collection of 450 mL BloodY-Sampling Site, DonorCare Needle Guard, 16 ga. Ultra Thin Wall NeedleRx only Each unit consists of PL 146 Plastic primary container with 63 mL of CPDA-1 solution containing g Dextrose (monohydrate) USP, 1.66 Sodium Citrate (dihydrate) USP, 188 mg Citric Acid (anhydrous) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP and 17.3 mg Adenine USP, pH may have been adjusted with sodium hydroxide; an integral RS-2000 filter with one empty 450 mL PL 146 Plastic container forred cell storage and one empty 400 mL PL 146 Plastic Transfer Pack(TM) container.Sterile, nonpyrogenic fluid pathSee instructions for use.Store at Controlled Room Temperature (refer to direction insert). oOpen pouch by tearing across at notch.oUnused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture.oDirect handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.oUnits removed from the foil pouch must be used within days (96 hours). Units out of the foil pouch for longer than days must be discarded.U.S Pat. Nos. RE 35,804; 5,314,421; 5,372,143; 5,507,525; 6,132,413; pat. pend.FENWAL, BLOOD-PACK, and TRANSFER PACK are trademarks of Fenwal, Inc.PL 146 is trademark of Baxter International, Inc.Sepacell is registered trademark of Asahi Kasei Medical Co., Ltd.DonorCare is trademark of ITL Corporation Fenwal, Inc. Lake Zurich, IL 60047 USAMade in USA07-28-02-794 REV: A. oOpen pouch by tearing across at notch.. oUnused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture.. oDirect handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.. oUnits removed from the foil pouch must be used within days (96 hours). Units out of the foil pouch for longer than days must be discarded.. logo. Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack(TM) Unit; Integral Sepacell RS-2000 Whole Blood Leukocyte Reduction Filter label.

SPL UNCLASSIFIED SECTION.


BLOOD-PACK(TM) Unit with an Integral SEPACELL(TM) RS-2000 Whole Blood Leukocyte Reduction Filter for Collection and Filtration of Whole Blood Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1). Rx only Contains Y-Sampling Site for the collection of unanticoagulated whole blood samples for laboratory testing and the DONORCARE(TM) Needle Guard.Integral filter unit intended for leukocyte reduction of whole blood up to hours after blood collection when whole blood is stored at ambient temperature or up to 72 hours after blood collection when whole blood is refrigerated. The leukocyte reduced blood products may then be stored for the maximum allowable dating period.Instructions for UseCollection Procedure:Use aseptic technique.Note: Nominal tubing dimensions of product are 0.118 inner diameter 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:oDo not use unless the solutions are clear.oBefore beginning procedure, obtain one access device for each BLOOD-PACK(TM) 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 Y-Sampling Site with hemostat. This step may be performed prior to step or 2.4.Apply pressure to donors 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 hemostat.8.When good blood flow is established, slide the DONORCARE(TM) 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 donors 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 metal clip or appropriate alternate method.Precaution: Complete steps 13 22 within approximately 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:oIf the access device needs to be replaced, use 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.oIf 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.oThe 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 appropriately18.Release remaining pressure on donors 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:oListen for the 2nd click as the needle is drawn into the needle guard.oEnsure 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.Filtration Procedure:Note: The time of whole blood filtration may vary depending on processing option selected.a)Within hours of collection if whole blood is held at ambient temperature.b)Within 72 hours of collection if whole blood is refrigerated following collection.23.Mix unfiltered whole blood thoroughly. Invert the primary container and hang the filter set such that the filter remains vertical. To achieve maximum flow rate, allow set to hang to full length.Note: The storage container must remain below the level of the filter during filtration.24.Inspect all tubing to insure it hangs freely without kinks. Install clamp on vent line and close. (4R4423 clamp recommended).25.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 the filtration of whole blood is initiated at ambient temperature and not completed within hours after blood collection, then filtration should be completed between and 6C.26.When flow stops, open the clamp and gently squeeze the filtered whole blood container until the air is expelled through the vent line and filtered blood fills the donor segment tubing as desired.27.Allow filtration to continue until the inlet side of the filter is filled with air.28.Seal the transfer tubing below the filter. Also seal the vent line tubing directly above the top donor segment number (near the slide clamp). At each location, seal in three places and cut the middle seal being careful to avoid fluid splatter. Discard filter and primary container appropriately.Note: If QC sample is desired, thoroughly mix the filtered whole blood and strip the donor segment tubing. Use the last segment (or segments) as the QC sample.29.Make donor segments. Leave segments attached to the filtered whole blood container.Component Preparation Procedure:Note: Platelet concentrates are not intended to be made with this product.30.Centrifuge filtered whole blood and secondary containers to prepare CPDA-1 red blood cells using the appropriate spin condition.31.Place filtered whole blood container in plasma extractor, and express plasma into empty TRANSFER PACK(TM) container by releasing pressure plate and opening closure in tubing of filtered whole blood container.32.When the desired amount of plasma has been removed, clamp the tubing between and plasma container. Seal transfer tubing in three places. Cut the middle seal, being careful to avoid fluid splatter.33.Seal transfer tubing in three places near the container of filtered red blood cells. Cut the middle seal, being careful to avoid fluid splatter.34.For further processing of plasma product with multiple BLOOD-PACK units, use standard component processing and storage techniques.Note: Fresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18C or colder within hours after blood collection.35.Store suspended CPDA-1 whole blood/red blood cells, Leukocytes Reduced between and 6C.36.Infuse CPDA-1 whole blood/red blood cells, Leukocytes Reduced within 35 days of collection.Store at Controlled Room Temperature.USP Definition of Controlled Room TemperatureUnited States Pharmacopeia, General Notices.United States Pharmacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MDFENWAL, BLOOD-PACK and TRANSFER PACK are trademarks of Fenwal, Inc.SEPACELL is trademark of Asahi Kasei Medical Co., Ltd.DONORCARE is trademark of ITL Corporation.(C) 2010 Fenwal, Inc. All rights reserved.- ManufacturerFenwal, Inc. Lake Zurich, IL 60047 USAMade in USA1-800-933-692507-19-04-639 REV: 03/2010. oDo not use unless the solutions are clear.. oBefore beginning procedure, obtain one access device for each BLOOD-PACK(TM) 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 Y-Sampling Site with hemostat. This step may be performed prior to step or 2.. 4.Apply pressure to donors 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.. 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 hemostat.. 8.When good blood flow is established, slide the DONORCARE(TM) 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). 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 donors arm as appropriate.. 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 metal clip or appropriate alternate method.. 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).. 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.. oIf the access device needs to be replaced, use 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.. oIf 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.. oThe access device can only be replaced one time.. 18.Release remaining pressure on donors arm.. 19.If desired, apply hemostat to donor tubing between needle and Y-Sampling Site.. 20.Withdrawal of Needle (see Figure 3). 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:oListen for the 2nd click as the needle is drawn into the needle guard.oEnsure the tubing cannot be pulled through the needle guard.. oListen for the 2nd click as the needle is drawn into the needle guard.. oEnsure 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.. 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.. a)Within hours of collection if whole blood is held at ambient temperature.. b)Within 72 hours of collection if whole blood is refrigerated following collection.. 23.Mix unfiltered whole blood thoroughly. Invert the primary container and hang the filter set such that the filter remains vertical. To achieve maximum flow rate, allow set to hang to full length.. 24.Inspect all tubing to insure it hangs freely without kinks. Install clamp on vent line and close. (4R4423 clamp recommended).. 25.Break the in-line cannula above the filter to start filtration.. 26.When flow stops, open the clamp and gently squeeze the filtered whole blood container until the air is expelled through the vent line and filtered blood fills the donor segment tubing as desired.. 27.Allow filtration to continue until the inlet side of the filter is filled with air.. 28.Seal the transfer tubing below the filter. Also seal the vent line tubing directly above the top donor segment number (near the slide clamp). At each location, seal in three places and cut the middle seal being careful to avoid fluid splatter. Discard filter and primary container appropriately.. 29.Make donor segments. Leave segments attached to the filtered whole blood container.. 30.Centrifuge filtered whole blood and secondary containers to prepare CPDA-1 red blood cells using the appropriate spin condition.. 31.Place filtered whole blood container in plasma extractor, and express plasma into empty TRANSFER PACK(TM) container by releasing pressure plate and opening closure in tubing of filtered whole blood container.. 32.When the desired amount of plasma has been removed, clamp the tubing between and plasma container. Seal transfer tubing in three places. Cut the middle seal, being careful to avoid fluid splatter.. 33.Seal transfer tubing in three places near the container of filtered red blood cells. Cut the middle seal, being careful to avoid fluid splatter.. 34.For further processing of plasma product with multiple BLOOD-PACK units, use standard component processing and storage techniques.. 35.Store suspended CPDA-1 whole blood/red blood cells, Leukocytes Reduced between and 6C.. 36.Infuse CPDA-1 whole blood/red blood cells, Leukocytes Reduced within 35 days of collection.. Representative Product Drawing. logo. logo.