PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE/LABEL DISPLAY PANEL. Code 4R6001 UnitsFenwal(TM)Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack(TM) UnitQuadruple For Collection of 250 mL BloodY-Sampling Site, DonorCare Needle Guard, 16 ga. Ultra Thin Wall NeedleRx onlyEach unit consists of PL 146 Plastic primary container with 35 mL of CPDA-1 solution containing 1.12 Dextrose (monohydrate) USP, 921 mg Sodium Citrate (dihydrate) USP, 105 mg Citric Acid (anhydrous) USP, 78 mg Monobasic Sodium Phosphate (monohydrate) USP and 9.6 mg Adenine USP, pH may have been adjusted with sodium hydroxide; three empty 150 mL PL 146 Plastic Transfer Pack Containers.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.U.S. Pat. Nos.: 5,314,421; 5,507,525; 5,372,143FENWAL, BLOOD-PACK, and TRANSFER PACK are trademarks of Fenwal, Inc.PL 146 is trademark of Baxter International Inc.DonorCare is trademark of ITL Corporation.Fenwal, Inc. Lake Zurich, IL 60047 USAMade in USA07-28-57-88905/2008. 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.. logo. Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack(TM) Unit label.

SPL UNCLASSIFIED SECTION.


Instructions for Blood Collection Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) BLOOD-PACK(TM) Units. Rx only Contains Y-Sampling Site for the collection of unanticoagulated whole blood samples for laboratory testing and the DONORCARE(TM) Needle Guard.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 solution is 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 21 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 appropriately.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)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.Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once.22.Seal at marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.Note: Step 23 may be performed prior to step 21 or 22 if desired.23.Remove and discard the Y-Sampling Site and the DONORCARE Needle Guard into an appropriate biohazardous waste container following established procedures.24.Component Preparation:oIf platelet concentrate is to be prepared, it should be separated from the red blood cells within hours after blood collection.oFresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18C or colder within hours after blood collection.25.When processing multiple BLOOD-PACK unit, centrifuge primary and secondary containers to prepare CPDA-1 red blood cells.26.Place primary container in plasma extractor and express plasma into the appropriate empty TRANSFER-PACK(TM) container by releasing pressure plate and opening closure in tubing of primary container.27.When desired amount of plasma has been removed, clamp tubing between and plasma container.28.Hermetically seal and separate transfer tubing between the Y-connector and primary container. Be careful to avoid fluid splatter.29.For further processing with multiple BLOOD-PACK units, use standard component processing and storage techniques.30.Store suspended CPDA-1 whole blood/red blood cells between and 6C.31.Infuse CPDA-1 whole blood/red blood cells 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, Inc. Lake Zurich, IL 60047 USA1-800-933-692507-19-06-112 REV: A06/2011ManufacturerFENWAL, BLOOD-PACK and TRANSFER-PACK are trademarks of Fenwal, Inc.DONORCARE is trademark of ITL Corporation(C) 2011 Fenwal, Inc. All rights reserved. oDo not use unless the solution is 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) 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.. 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.. 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.Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once.. 22.Seal at marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.. 23.Remove and discard the Y-Sampling Site and the DONORCARE Needle Guard into an appropriate biohazardous waste container following established procedures.. 24.Component Preparation:oIf platelet concentrate is to be prepared, it should be separated from the red blood cells within hours after blood collection.oFresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18C or colder within hours after blood collection.. oIf platelet concentrate is to be prepared, it should be separated from the red blood cells within hours after blood collection.. oFresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18C or colder within hours after blood collection.. 25.When processing multiple BLOOD-PACK unit, centrifuge primary and secondary containers to prepare CPDA-1 red blood cells.. 26.Place primary container in plasma extractor and express plasma into the appropriate empty TRANSFER-PACK(TM) container by releasing pressure plate and opening closure in tubing of primary container.. 27.When desired amount of plasma has been removed, clamp tubing between and plasma container.. 28.Hermetically seal and separate transfer tubing between the Y-connector and primary container. Be careful to avoid fluid splatter.. 29.For further processing with multiple BLOOD-PACK units, use standard component processing and storage techniques.. 30.Store suspended CPDA-1 whole blood/red blood cells between and 6C.. 31.Infuse CPDA-1 whole blood/red blood cells within 35 days of collection.. Representative Product Drawing. logo. logo.