CPDA-1 Blood Collection System (Page 2 of 2)

III. WHEN USING SYSTEMS WITH A PRE-ATTACHED SAMP LOK ® VACUUM TUBE HOLDER

1. To collect blood samples, open lid from Samp Lok vacuum tube holder.

2. Open snap-open closure between sample diversion pouch and Samp Lok vacuum tube holder.

3. Position the sample diversion pouch downwards so that the air rises to the top of the pouch and away from the Samp Lok vacuum tube holder. Note: Drawing air into the vacuum tube may cause hemolysis.

4. Collect blood samples from the sample diversion pouch into vacuum tubes within approximately four minutes to avoid possible clot formation.

5. Ensure the vacuum tubes are centered within the Samp Lok vacuum tube holder during sample collection.

6. Maintain forward pressure on the vacuum tubes during sample collection.

7. The lid may be closed on the Samp Lok vacuum tube holder after sample collection.

8. Return to Section II, Step 17. Note: When collection of unit is complete and the donor needle is engaged in the DCNG, open the lid of the Samp Lok vacuum tube holder and insert the DCNG into the holder. Twist until it locks into place. An audible click will confirm that it is locked.

IV. PROCESSING INSTRUCTIONS

1. If desired, seal at or adjacent to “X” marks on the tubing to provide numbered segments of anticoagulated blood for typing or crossmatching.*

2. Load whole blood and remaining bags into centrifuge cup, ensuring that the tubing stays in the top half of the cup.

3. Centrifuge at conditions designed to produce desired components.

4. Carefully remove the unit from the centrifuge and place the collection bag in the plasma expressor.

5. Clamp tubing to extra satellite bag(s), if present.

6. Gently apply expressor pressure.

7. Open snap-open closure on collection bag and express plasma.

8. After plasma is expressed, clamp tubing between satellite bag(s) whole blood bag and release expressor pressure.

9. Seal tubing and detach the bag containing packed red cells, and set aside plasma for further processing.*

10. Gently mix packed red cells.

11. Store CPDA-1 preserved red blood cells at 1—6 °C for up to 35 days and use as indicated.

HOW SUPPLIED

Each shipping case contains 8 foil envelopes. Within each foil envelope resides 3 units of the collection system. Each unit consists of a collection bag with 63 ml of CPDA-1 solution and one empty bag.

REFERENCES

HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.

DonorCare and SampLok are registered trademarks of ITL Corporation, Canberra, Australia.

Manufactured for:

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

By: Haemonetics Manufacturing Inc.

1630 Industrial Park Street

Covina, CA 91722, USA

www.haemonetics.com

800-537-2802

IFU P/N 147130924

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Envelope Label
(click image for full-size original)

Envelope Label

Collection Bag Label
(click image for full-size original)

Collection Bag Label

Plasma Bag Label
(click image for full-size original)

Plasma Bag Label

CPDA-1 BLOOD COLLECTION SYSTEM
blood collection system solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-730
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.01 g in 63 mL
SODIUM CITRATE (ANHYDROUS CITRIC ACID and SODIUM CATION) SODIUM CITRATE 1.66 g in 63 mL
CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 0.206 g in 63 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.14 g in 63 mL
ADENINE (ADENINE) ADENINE 0.017 g in 63 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53157-730-92 24 BAG in 1 CARTON contains a BAG
1 63 mL in 1 BAG This package is contained within the CARTON (53157-730-92)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA BN800077 11/06/1980
Labeler — Haemonetics Corporation (057827420)
Establishment
Name Address ID/FEI Operations
Haemonetics Corporation 057827420 label (53157-730)
Establishment
Name Address ID/FEI Operations
Haemonetics Manufacturing Inc 078598396 manufacture (53157-730)

Revised: 01/2021 Haemonetics Corporation

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.