WARNING: All medications should be closely monitored to detect any alterations in the effective concentration due to the ultrafiltration process.

Transcription

1 HEMOBAG BSD2000 Product Code: HBBSD2000 Caution: Federal (USA) law restricts this device to sale by or on the order of a physician Product Description The patented HEMOBAG autotransfusion device is a blood storage reservoir for blood that can be circulated, hemoconcentrated and transfused back to the same patient as a form of autologous whole blood management and conservation. It is designed for salvaging anticoagulated whole blood from cardiopulmonary bypass circuits and other extracorporeal circuits and reservoirs, and can be hemoconcentrated by ultrafiltration. Indications for Use: (FOR SINGLE USE ONLY, DO NOT RESTERILIZE) The HEMOBAG Blood Salvage Device is a blood storage reservoir for blood that can be circulated and hemoconcentrated. It is designed for use in salvaging anticoagulated whole blood from extracorporeal circuits and reservoirs. When used in connection with the TS3 Tubing Set and a commercially available hemoconcentrator, the HEMOBAG serves as a hemoconcentrating reservoir for use in a closed circuit recovery loop for the removal of excess plasma water, low molecular weight solutes and platelet inhibitors. This patented processing method concentrates the diluted anticoagulated whole blood within the closed circulatory recovery loop of the TS3 Tubing Set and the HEMOBAG blood salvage device producing a richly concentrated, anticoagulated, autologous whole blood product for autotransfusion that is quickly made available for Infusion. The HEMOBAG is designed only for use with TS3 Tubing set and any commercially available hemoconcentrator with universal dialysis connectors or ¼ outlet posts. Contraindications The HEMOBAG is designed and sold for use only as indicated. The responsibility for the use of this device belongs solely to the prescribing physician. WARNING: Protamine is specifically contraindicated for use within this device. Other medications (i.e., anticoagulants) should be monitored to ensure Activated Clotting Times are satisfactory for anticoagulation. The responsibility for levels and adjustments of medications in the circulatory path of these products, HEMOBAG, TS3 Tubing Set, and any associated hemoconcentrator is that of the prescribing physician. WARNING: All medications should be closely monitored to detect any alterations in the effective concentration due to the ultrafiltration process. General Warnings Read all instructions and warnings before use. Specific warnings related to the set up and use of this device or system are in Bold print in the various sections of these instructions. Specific attention must be devoted to understanding these warnings. Use of this product is limited by law (USA) to supervision by a licensed medical practitioner. Product must be set up and utilized by personnel trained in the use of extracorporeal and cardiopulmonary circuits, devices and reservoirs. All gas bubbles have the potential of becoming gaseous emboli, and therefore must be dealt with carefully. Remove all gaseous bubbles from the HEMOBAG before hemoconcentrating and gravity infusing the blood. Product is Sterile and Non-Pyrogenic if package is sealed and undamaged. Do not use if the package is damaged or opened as this may lead to harm to the patient due to contamination. Connector covers should remain on device until time of connection. Single Use Only! Reuse of the product may cause harm to the patient due to contamination. Do not Re-sterilize. Removed wording and inserted wording nest page about Avoid Temperatures above 50 etc Autologous blood is a very precious substance; therefore, once the HEMOBAG has been filled it must be handled with care (Autologous whole blood is considered to be the most precious substance on the earth). Dispose of product in accordance with OSHA Regulations for Bloodborne Pathogens. Page 1 of 5 DFU HBBSD /2017

2 Avoid contact with halogenated hydrocarbon based anesthetic agents as they attack plastics. Do not store blood in the HEMOBAG for extended periods of time. It is recommended to following the AABB Guidance for Standards for Perioperative Autologous Blood Collection and Administration when using this device. Note: When returning heparinized concentrated whole blood back to the patient, it may be necessary to administer additional Protamine to the patient to reverse the effects of the heparin. General Precaution Avoid exposure to temperatures above 50 C, or below 0 C. Store in a clean, dry location. Instructions for Use Filling the HEMOBAG (Step by Step) Schematics of Product - Figure #1. The numbers on the schematic correspond with the numbers noted below in the instructions for use. Precaution: Use aseptic technique when making all connections. Verify package has not been damaged or opened. Do not use if package is damaged or open. Open the HEMOBAG onto a sterile field using aseptic techniques. Once the package has been opened, protect all connections by placing leash caps and plugs in or on the appropriate connectors. Assure all other caps and clamps of the HEMOBAG are closed. Open the top Arterial Infusion Port 2H by sliding the large white Slide Clamp or Master Clip 3H and removing the Green Cap 4H. The HEMOBAG is ready to be filled by way of the sterile field after the Arterial or forward flow line is removed from the patient and free (make sure that all slide clamps are securely closed). Before pumping the blood into the HEMOBAG, drain all blood-filled lines (i.e., venous line, cardioplegia lines, manifold and sampling lines, etc.) back to the extracorporeal circuit s reservoir. Attach the arterial or forward flow line (or drainage port) of the extracorporeal circuit to the ¼ to 3/8 stepped Universal Arterial Infusion Connector 1H (Port with the Green Cap) at the top of the HEMOBAG. Blood from the extracorporeal circuit or reservoir is flushed (or drained) into the HEMOBAG using crystalloid solution to displace the blood in the extracorporeal circuit. The crystalloid solution is kept in the extracorporeal circuit in order to keep it primed and ready for use. The HEMOBAG will hold a maximum of 2000 milliliters of fluid from any extracorporeal circuit. WARNING: DO NOT OVERFILL the HEMOBAG. Maximum volume of HEMOBAG is 2000 milliliters of fluid. Graduation markings on the HEMOBAG represent approximate volumes and should not be used to measure the exact volume of fluid. When the HEMOBAG has been filled (2000 ml Maximum) and the extracorporeal circuit has been primed with crystalloid solution, clamp off the arterial or forward flow line with a tubing clamp and close the HEMOBAG using the Master Clip 3H. Detach the fill line from the Arterial Infusion Port 1H of the HEMOBAG. Purge the air from the HEMOBAG, close the Master Clip 3H tightly and firmly place the Green Cap 4H onto the Arterial Infusion Port. Wipe the exterior of the bag clean if needed. The HEMOBAG is now a closed, sterile reservoir of blood that can be carefully connected to the closed hemoconcentrating recovery loop consisting of the HEMOBAG, the TS3 Tubing Set, a hemoconcentrator, a ¼ inch recirculating pump that is not in use at the time and a pressure transducer. Instructions for Use withts3 Tubing Set (Step by Step) Hang the HEMOBAG using the Master Clip 3H at the top of the bag carefully. A QC sample may be drawn at this time from the needle-less sampling port for baseline lab values Note: Before connecting the HEMOBAG to the TS3 Tubing Set, ensure the TS3 Tubing Set recovery loop and hemoconcentrator have been set up, primed and all air has been removed in accordance with the TS3 Directions for Use. Note: Before connecting the HEMOBAG to the TS3 Tubing Set, verify the TS3 s recovery loop Inlet Line (Blue pinch Clamp 8T) is going into a roller or positive displacement pump and the forward flow from the pump is connected to a hemoconcentrator such that the hemoconcentrator s outlet flow tubing (Red Pinch Clamp 3T) will go back into the HEMOBAG creating the closed hemoconcentrating recovery loop. (make sure that there is at least 2 inches of ¼ line between the roller head and the Y before the hemoconcentrator) Helpful Tip: The male luer on the inflow line of the standard loop (9T now with a white cover cap) before the Y at the bottom of the hemoconcentrator should be connected to a pressure transducer to observe hemoconcentrating pressures. Page 2 of 5 DFU HBBSD /2017

3 Remove the Yellow Dust Cap 18H from the Needle-less Sampling Port 14H on the side of the of the HEMOBAG. Connect the Male Connector 7H (Blue capped connector) of the HEMOBAG to the Female Inlet Line connector 7T (Blue Pinch Clamp) of the TS3 Tubing going to the roller pump. Connect the Male Outlet Line Connector 6T of the TS3 Tubing Set from the hemoconcentrator (Red pinch Clamp3T) to the Female connector 10H (Red Cap Plug 11H) of the HEMOBAG. You are now ready to circulate the fluid in the closed hemoconcentrating Recovery Loop. WARNING: Verify that the Yellow Dust Cap 18H has been removed from the Needle-less Sampling Port in order to prevent blood from leaking out of the sampling port. At this point, the HEMOBAG and TS3 Tubing Set should look like this: Open the slide clamps on the Inlet 12H and Outlet 6H Ports of the HEMOBAG and open the Red 3T and Blue 8T Pinch Clamps of the TS3 Tubing Set Recovery loop. Allow the small amounts of air from the connections to rise to the top of the HEMOBAG. Slowly start the roller pump circulating the flow of blood from the HEMOBAG male connector 7H (Blue Cap 8H) through the roller pump, to the hemoconcentrator, and then from the hemoconcentrator back to the female connector 10H (Red Cap Plug 11H) of the HEMOBAG completing the closed hemoconcentration Recovery Loop. WARNING: Verify there is no build up of pressure in the TS3 Tubing Set by squeezing the tubing between your fingers distal to the roller pump and proximal to the hemoconcentrator at the start of circulation and periodically throughout ultrafiltration process. For convenience the inflow line male luer of the standard loop distal to the roller pump and proximal to the hemoconcentrator should be connected to a pressure transducer to observe hemoconcentrating pressures. It also necessary to agitate the Page 3 of 5 DFU HBBSD /2017

4 A P P RO XIM A TE VO LUM E (M ILLI LITE RS ) ANTICOAGULATED BLOOD ONLY D O NOT PRE S S URI ZE m l m ax OR HEMOBAG U S P A TE NT /2 1 /3 1 /4 Hemobag by squeezing the bag from both sides at least once every minute or so to insure optimal mixing occurs. This will lessen the hemoconcentrating pressures in the Recovery loop as the blood becomes more concentrated. WARNING: When using the HEMOBAG and the TS3 Tubing Set with a commercial hemoconcentrator, DO NOT exceed the recommended flow rates, pressure, and maximum hematocrit levels in the Directions for Use of the hemoconcentrator when concentrating blood. When the blood in the closed hemoconcentrating Recovery Loop and HEMOBAG have reached a satisfactory level of fluid reduction (not to exceed a HCT of 50%), stop the roller pump, A QC sample may be drawn at this time from the needle-less sampling port. Now close the HEMOBAG using Slide Clamp (Blue) 6H Securely. Flush the TS3 Tubing Set by chasing a small amount of crystalloid fluid through the Needle-less Sampling port luer 14H on the side of the HEMOBAG outlet port (a 60cc syringe may be used for this step and disconnected) do this by starting the roller pump again, pump the blood in the TS3 Tubing Set Recovery loop and hemoconcentrator back through Inlet (Red Cap Plug 11H) Port 13H into the HEMOBAG. When crystalloid fluid or air is seen exiting the hemoconcentrator, stop the roller pump and close the HEMOBAG using the Slide Clamp (Red) 12H Securely. Close the Red pinch clamp 3T and the Blue Pinch clamp 8T before disconnecting; All Clamps are closed securely now. Disconnect the HEMOBAG from the closed hemoconcentration Recovery Loop and Cap the (Red Plug Cap 11H), and the (Blue Cap 8H) of the HEMOBAG, then reconnect the 2 ends (Male Connector 6T and Female Connector 7T) of the TS3 Tubing Set to close the Recovery Loop. Apply the completed Patient Information Label to the side of the HEMOBAG. The HEMOBAG is now ready to be handed off for rapid autologous whole blood gravity infusion through the large bore IV line infusion port 9H. Note: Ensure the HEMOBAG is free of any air or bubbles before beginning nonpressurized gravity infusion. Note: For Jehovah s Witness Patients, retrograde prime an I.V. pressure Line and 3 way stopcock to the Inlet port luer (17H) of the HEMOBAG and the patient prior to filling the HEMOBAG from the Arterial or forward flow line. (See Note: When utilizing the HEMOBAG with a system outside of the traditional CPB extracorporeal circuit, be sure to have the closed TS3 tubing set and hemoconcentrator Set Up and Primed before connecting the HEMOBAG and the tubing sets Recovery Loop. (Refer to the TS3 Package Insert for Instructions) 1H U niversal 1/4" - 3/8" C onnec tor 13H 2H Arterial Infusion Port 12H Red Slide Clamp 17H Male Luer 11H Inlet P ort Female Connector Red Plug 10H Female Connector 9H IV Line Transfusion Port B af fle 16H 7H M ale Connector 3H Master Clip W hite S lide Clam p Blue Slide Clamp 5H 6H 8H M ale Connector Blue Cap 4H Green Cap Transfusion Port W hite S lide Clam p 15H 14H N eedless S am pling M ale Luer 18H Yellow Vented Cap FIGURE 1 Page 4 of 5 DFU HBBSD /2017

5 WARRANTY WARRANTY- LIMITATION OF LIABILITY: GLOBAL BLOOD RESOURCES LLC (GBR) MAKES NO EXPRESS OR IMPLIED WARRANTIES OF ANY KIND INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. GBR S SOLE OBLIGATION AND PURCHASER S EXCLUSIVE REMEDY IN THE EVENT THAT THE PRODUCT CANNOT BE CONFIGURED OR DOES NOT PERFORM IN ACCORDANCE WITH THE INSTRUCTIONS CONTAINED HEREIN, SHALL BE, TO REPLACE THE PRODUCT UPON RETURN OF THE ORIGINALLY PURCHASED PRODUCT. GBR SHALL NOT BE LIABLE IN TORT, CONTRACT OR ANY OTHER ACTION FOR SPECIAL, PROXIMATE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING FROM THE USE OR MISUSE OF THIS PRODUCT. LIMITED PATENT LICENSE: this product and the process of salvaging blood as described in the instructions are covered by one or more U.S. Patent No. 5,928,178. 6,398,751. 7,033,334 and and additional U.S. and foreign patents pending. Any authorized purchaser of this product acquires an implied license under these patents to use the product only one time for performing the method only one time, and acquires no other right or license under the patents. Manufactured For: Global Blood Resources, LLC Emergo Europe P.O. Box 383 Somers, CT USA Prinsessegracht 20 Tel (800) AP The Hague Fax (860) The Netherlands Manufactured By: Robling Medical, Incorporated 90 Weathers Street Youngsville, NC USA Page 5 of 5 DFU HBBSD /2017