PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE/LABEL DISPLAY PANEL. Code 4R3328 12 UnitsFenwal(TM)Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) BLOOD-PACK(TM) Unit; Integral SEPACELL(TM) RS-2000 Whole Blood Leukocyte Reduction FilterDouble For Collection and Processing of 450 mL BloodSample Diversion System, DONORCARE(TM) Needle Guard, 16 ga. Ultra Thin Wall NeedleRx onlyEach 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 for red cell storage and one empty 400 mL PL 146 Plastic TRANSFER-PACK(TM) container.Sterile, non-pyrogenic fluid path See instructions for use.Store at Controlled Room Temperature (refer to direction insert).oOpen pouch by tearing across at notch.oDirect handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.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, provided:I)Units are not removed from foil pouch, orII)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.oUnits removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.FENWAL, BLOOD-PACK, and TRANSFER PACK are trademarks of Fenwal, Inc.DONORCARE is trademark of ITL Corporation.SEPACELL is trademark of Asahi Kasei Medical Co., Ltd.Fenwal, Inc.Lake Zurich, IL 60047 USAMade in USA07-28-05-462 REV: A. oOpen pouch by tearing across at notch.. oDirect handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.. 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, provided:I)Units are not removed from foil pouch, orII)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.. 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.. oUnits removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.. logo. Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) BLOOD-PACK(TM) Unit; Integral SEPACELL(TM) 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 Sample Diversion System for the collection of whole blood samples for laboratory testing. Also includes the DONORCARE(TM) Needle Guard.Integral filter unit intended for leukocyte reduction of whole blood up to 72 hours after blood collection. The leukocyte reduced blood products may then be stored for the maximum allowable dating period.Instructions for UseCollection Procedure:Use aseptic technique.Notes:oIf Sample Diversion System is not used, donor samples may be collected using an alternate method following standard procedures.oNominal tubing dimensions of product are 0.118 inner diameter 0.025 wall thickness.Precautions:oUpon removal of BLOOD-PACK(TM) unit from the clear plastic overwrap, visually inspect the unit.oDo not use the product if the in-line cannula is broken and/or anticoagulant is present in the sample pouch or in the tubing from the in-line cannula to the sample pouch and donor needle (see Figure 1). Note that condensation in the empty tubing of the BLOOD-PACK unit is expected as result of the sterilization process.oDo not use unless the solutions are clear.1.Identify BLOOD-PACK unit using appropriate donor identification system.2.Donor scaleoAdjust donor scale to desired collection weight.oPosition primary container on the donor scale as far as possible below donor arm.3.Clamp donor tubing between the needle and Y-junction with hemostat. (This step can be performed prior to step or 2.)4.Visually inspect the tubing from the in-line cannula to the sample pouch and donor needle, as well as the sample pouch to reconfirm that there is no anticoagulant present.Note: Ensure that the sample pouch remains below the donors arm.5.Following blood center procedures, apply pressure to donors arm and disinfect site of venipuncture.6.Remove needle cover per instructions below:oHolding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.oRemove needle cover, being careful not to drag the cover across the needle point.7.Following blood center procedures, 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 2) 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. Appropriately secure needle and/or tubing. 9.Allow the sample pouch to fill with blood according to center procedure. Monitor blood flow into sample pouch.Notes:oThe sample pouch contains an average fill volume of approximately 53 mL with maximum fill volume of approximately 60 mL when filled to capacity.oIf less blood sample volume is required, the flow to the sample pouch may be stopped prior to completely filling the pouch. For example, in order to target fill volume of approximately 40 mL, fill to the level indicated by the arrows in Figure 1. Ensure the pouch is hanging vertically.oThe tube leading from the Y-junction to the sample pouch contains an additional volume of approximately mL.Precautions:oDo not elevate or squeeze the sample pouch as this could cause blood to backflow from the sample pouch into the collection system.oOnce the sample pouch is filled to desired volume, complete steps 10 18 within approximately minutes to avoid possible clot formation in the tubing and/or sample pouch.10.Close the blue clamp on tubing between the Y-junction and the sample pouch.11.Break the in-line cannula below the Y-junction in the donor tubing to the primary container allowing blood collection to proceed. To completely break the in-line cannula, grasp with both hands. Snap it at 90 angle in one direction, and then bend it at 90 angle in the opposite direction. Ensure the in-line cannula is completely broken and that the blood flows freely to the primary container.Precaution: Failure to break the in-line cannula completely may result in restricted blood flow.12.Following blood center procedures, mix blood and anticoagulant in the primary container immediately and at several intervals during collection.13.Following blood center procedures, hermetically seal the tubing between the sampling site and the Y-junction to maintain sterility of the blood collection system prior to removing blood samples.Warning:oDo not proceed with the remaining steps until the tubing leading to the sample pouch is hermetically sealed between the sampling site and the Y-junction. To maintain the whole blood collection container as closed system, the tubing between the sample pouch and Y-junction must be hermetically sealed prior to inserting the access device into the sampling site. Failure to do so may lead to contamination of the whole blood collection.14.Insert the access device by pushing firmly into the sampling site until the membrane seal is penetrated.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.15.Open the cap on the access device (if applicable). Hold access device so that the sample pouch hangs down.16.Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device.17.Allow vacuum sample tube to fill with blood then remove from the access device.18.Repeat steps 16 and 17 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 sampling site and the sample pouch. 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 access device, be careful to avoid contact with any blood droplets on the Luer or sampling site. Discard used access device appropriately.19.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%.Precaution: Once the desired blood volume is collected, complete steps 20-24 within approximately minutes to avoid possible clot formation in the tubing.20.Release pressure on the donors arm. If appropriate, apply hemostat to donor tubing between the needle and the Y-junction.21.Hermetically seal donor tubing between the in-line cannula and the primary container.22.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.23.Remove and discard the Sample Diversion System and needle guard into an appropriate biohazardous waste container following established procedures.Note: Step 24 may be performed prior to step 23 if desired.24.If the donor tubing is not sealed directly above the primary container, then strip the blood from the remaining donor tubing into the primary container. Mix and allow the tubing to refill; repeat once.Filtration Procedure:Precaution: Whole blood collected from certain donors may have extended filtration times and the potential for ineffective filtration and leukoreduction.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.25.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.26.Inspect all tubing to insure it hangs freely without kinks. Install clamp on vent line and close. (4R4423 clamp recommended).27.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.28.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.29.Allow filtration to continue until the inlet side of the filter is filled with air.30.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.31.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.32.Centrifuge filtered whole blood and secondary containers to prepare CPDA-1 red blood cells using the appropriate spin condition.33.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.34.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.35.Seal transfer tubing in three places near the container of filtered red blood cells. Cut the middle seal, being careful to avoid fluid splatter.36.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.37.Store suspended CPDA-1 whole blood/red blood cells, Leukocytes Reduced between and 6C.38.Infuse CPDA-1 whole blood/red blood cells, Leukocytes Reduced within 35 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 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 USA1-800-933-692507-19-04-637 REV: 03/2010. oIf Sample Diversion System is not used, donor samples may be collected using an alternate method following standard procedures.. oNominal tubing dimensions of product are 0.118 inner diameter 0.025 wall thickness.. oUpon removal of BLOOD-PACK(TM) unit from the clear plastic overwrap, visually inspect the unit.. oDo not use the product if the in-line cannula is broken and/or anticoagulant is present in the sample pouch or in the tubing from the in-line cannula to the sample pouch and donor needle (see Figure 1). Note that condensation in the empty tubing of the BLOOD-PACK unit is expected as result of the sterilization process.. oDo not use unless the solutions are clear.. 1.Identify BLOOD-PACK unit using appropriate donor identification system.. 2.Donor scaleoAdjust donor scale to desired collection weight.oPosition primary container on the donor scale as far as possible below donor arm.. oAdjust donor scale to desired collection weight.. oPosition primary container on the donor scale as far as possible below donor arm.. 3.Clamp donor tubing between the needle and Y-junction with hemostat. (This step can be performed prior to step or 2.). 4.Visually inspect the tubing from the in-line cannula to the sample pouch and donor needle, as well as the sample pouch to reconfirm that there is no anticoagulant present.Note: Ensure that the sample pouch remains below the donors arm.. 5.Following blood center procedures, apply pressure to donors arm and disinfect site of venipuncture.. 6.Remove needle cover per instructions below:oHolding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.oRemove needle cover, being careful not to drag the cover across the needle point.. oHolding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.. oRemove needle cover, being careful not to drag the cover across the needle point.. 7.Following blood center procedures, 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 2) 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. Appropriately secure needle and/or tubing. 9.Allow the sample pouch to fill with blood according to center procedure. Monitor blood flow into sample pouch.. oThe sample pouch contains an average fill volume of approximately 53 mL with maximum fill volume of approximately 60 mL when filled to capacity.. oIf less blood sample volume is required, the flow to the sample pouch may be stopped prior to completely filling the pouch. For example, in order to target fill volume of approximately 40 mL, fill to the level indicated by the arrows in Figure 1. Ensure the pouch is hanging vertically.. oThe tube leading from the Y-junction to the sample pouch contains an additional volume of approximately mL.. oDo not elevate or squeeze the sample pouch as this could cause blood to backflow from the sample pouch into the collection system.. oOnce the sample pouch is filled to desired volume, complete steps 10 18 within approximately minutes to avoid possible clot formation in the tubing and/or sample pouch.. 10.Close the blue clamp on tubing between the Y-junction and the sample pouch.. 11.Break the in-line cannula below the Y-junction in the donor tubing to the primary container allowing blood collection to proceed. To completely break the in-line cannula, grasp with both hands. Snap it at 90 angle in one direction, and then bend it at 90 angle in the opposite direction. Ensure the in-line cannula is completely broken and that the blood flows freely to the primary container.. 12.Following blood center procedures, mix blood and anticoagulant in the primary container immediately and at several intervals during collection.. 13.Following blood center procedures, hermetically seal the tubing between the sampling site and the Y-junction to maintain sterility of the blood collection system prior to removing blood samples.. oDo not proceed with the remaining steps until the tubing leading to the sample pouch is hermetically sealed between the sampling site and the Y-junction. To maintain the whole blood collection container as closed system, the tubing between the sample pouch and Y-junction must be hermetically sealed prior to inserting the access device into the sampling site. Failure to do so may lead to contamination of the whole blood collection.. 14.Insert the access device by pushing firmly into the sampling site until the membrane seal is penetrated.. 15.Open the cap on the access device (if applicable). Hold access device so that the sample pouch hangs down.. 16.Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device.. 17.Allow vacuum sample tube to fill with blood then remove from the access device.. 18.Repeat steps 16 and 17 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 sampling site and the sample pouch. 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.. 19.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%.. 20.Release pressure on the donors arm. If appropriate, apply hemostat to donor tubing between the needle and the Y-junction.. 21.Hermetically seal donor tubing between the in-line cannula and the primary container.. 22.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.. 23.Remove and discard the Sample Diversion System and needle guard into an appropriate biohazardous waste container following established procedures.. 24.If the donor tubing is not sealed directly above the primary container, then strip the blood from the remaining donor tubing into the primary container. Mix and allow the 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.. 25.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.. 26.Inspect all tubing to insure it hangs freely without kinks. Install clamp on vent line and close. (4R4423 clamp recommended).. 27.Break the in-line cannula above the filter to start filtration.. 28.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.. 29.Allow filtration to continue until the inlet side of the filter is filled with air.. 30.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.. 31.Make donor segments. Leave segments attached to the filtered whole blood container.. 32.Centrifuge filtered whole blood and secondary containers to prepare CPDA-1 red blood cells using the appropriate spin condition.. 33.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.. 34.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.. 35.Seal transfer tubing in three places near the container of filtered red blood cells. Cut the middle seal, being careful to avoid fluid splatter.. 36.For further processing of plasma product with multiple BLOOD-PACK units, use standard component processing and storage techniques.. 37.Store suspended CPDA-1 whole blood/red blood cells, Leukocytes Reduced between and 6C.. 38.Infuse CPDA-1 whole blood/red blood cells, Leukocytes Reduced within 35 days of collection.. Representative Product Drawing. logo. logo.