Return Of Used Products - sorin XRES T Instrucciones De Uso

Oxygenator Extension Line.
3. Whenever the Oxygenator Extension Line is directly connected to the Bowl Set,
ensure that all the clamps are open.
4. Transfer the priming fluid to the cell separator device following the instructions
for use of the device, taking care not to create any negative pressure within the
ECC circuit.
5. During the return of the concentrated priming fluid, avoid any air being routed
to the ECC circuit.
Recovery of priming residue from the ECC circuit (for Collection Set Cardio
only)
During cardiovascular operations, it is advisable to transfer the priming residue from
the ECC circuit to the reservoir, to minimize the time the pump console remains in the
operating theatre.
1. Clamp the aspiration line
2. Open both clamps on the Y adapter branches. Make sure the ¼'' tubing
segment connecting the Y Adapter to the reservoir is open. Remove the clamp
used on the 1/4" Adapter Tubing previously connected to the ECC circuit and
open any other clamp that may be present on the Oxygenator Extension Line
3. Transfer the priming residue to the reservoir from the ECC circuit until it is
completely empty, appropriately adjusting the vacuum.
4. After transferring the priming residue to the reservoir, close all the clamps
between the Y Adapter and the ECC circuit and remove the connection to the
circuit. The pump console is now free of connections and the blood processing
can start.
5. Reopen the aspiration line
Wash the recovered blood with at least the volume of saline solution
recommended in the instructions for use of SORIN GROUP ITALIA cell
separators for autotransfusion, to guarantee removal of excess
anticoagulant and other undesired components collected.
REINFUSING SALVAGED BLOOD
It is recommended that intraoperative and postoperative autologous blood
be processed. The washing operation is necessary whenever the recovery
is carried out in the presence of heavy haemolysis caused by surgery, or
in cases of high coagulopathy or hepatic or renal failure.
The decision to re-infuse the blood components obtained by this
concentration-washing procedure is the responsibility of the attending
physician.
Do not reinfuse the patient's blood from the primary reinfusion bag when it
is connected to the cell separator's wash circuit. Reinfusion from the
primary reinfusion bag connected to the circuit could lead to air embolism
to the patient.
Do not reinfuse under pressure (i.e., do not use a blood pressure cuff on
the secondary reinfusion bag). Reinfusion under pressure could lead to air
embolism.
To minimize the complications of particulate matter infusion, use of an in-
line microaggregate filter on the patient reinfusion line is highly
recommended. Failure to use an in-line filter may result in reinfusing
particles potentially harmful to the patient.
To reduce risk of air embolism, remove all air from the primary reinfusion
bag before handing the bag over for reinfusion.
The American Association of Blood Banks recommends the following
guidelines for expiration of salvaged blood
a. If not transfused immediately, units collected and processed under
sterile conditions with a device for intraoperative blood collection
that washes with 0.9% saline, USP, shall be stored under one of the
following conditions prior tocompletion of transfusion:
At room temperature for up to 4 hours after completion of
processing
at 1 °C to 6 °C for up to 24 hours, provided that storage at 1°C
to 6 °C is begun within 4 hours after completion of processing
b. The transfusion of shed blood collected under postoperative or
posttraumatic conditions shall be completed within 6 hours of
initiating the collection.
American Association of Blood Banks. Standards for Perioperative
1
Autologous Blood Collection and Administration. 3
MD: American Association of Blood Banks, 2007.
Using XRES Blood Collection Reservoir Quick Reinfusion Port
XRES T Blood Collection Reservoir
The XRES T Blood Collection Reservoir is provided with a pierceable port on the
bottom, to gravity drain blood out of the reservoir. This port can be accessed with a
spike connector and may be used to empty the reservoir in case needed, or to
quickly reinfuse the unprocessed salvaged blood to the patient, in emergency
situations.
Observe the following instructions to access the Quick Reinfusion Port:
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1. Shut off the vacuum source, pull the yellow tab on the vacuum port of the
reservoir lid, then raise the reservoir as high as needed
2. Insert a spike through the integral membrane
3. In case of quick reinfusion, completely prime the line before connection to
the patient
XRES B Blood Collection Reservoir
The XRES B Blood Collection Reservoir is provided with a ¼'' male outlet port on the
bottom, to gravity drain blood out of the reservoir. This port may be used to empty the
reservoir in case needed, or to quickly reinfuse the unprocessed salvaged blood to the
patient, in emergency situations.
Observe the following instructions to use the bottom outlet port as a Quick Reinfusion
Port:
1. Shut off the vacuum source, pull the yellow tab on the vacuum port of the
reservoir lid, then raise the reservoir as high as needed
2. Connect an infusion line to the ¼'' bottom outlet port male connector,
using an adapter if needed
3. In case of quick reinfusion, completely prime the line before connection to
the patient
Limit the reinfusion of unprocessed blood to the surgical situations of real
necessity. The decision and responsibility of reinfusing unprocessed
blood belongs solely to the physician in charge. When reinfusing
unprocessed blood, the use of a microaggregate filter on the patient
reinfusion line is mandatory.
MEDICAL DEVICES TO BE USED WITH THE
PRODUCTS
The XRES Blood Collection Reservoir, Collection Set Cardio and Collection Set
must be connected to the Sorin group italia Bowl Sets for removal of undesired
substances collected from the surgical field.
The connections to the product must be of a diameter which is compatible with
the dimensions of the connectors on the device (3/8" or 1/4").
The aspiration must be performed with SORIN GROUP ITALIA surgical
aspirator or other aspirators having compatible technical characteristics.
The User should observe the warnings and cautions and follow Instruction
for Use accompanying the separate device.

RETURN OF USED PRODUCTS

Should the user be dissatisfied with anything related to the quality of the product, the
product distributor or the authorized local SORIN GROUP ITALIA representative
should be notified.
All parameters considered critical by the user must be reported with particular care
and urgency. The following is the minimum information that should be provided:
Detailed description of the event and, if pertinent, the conditions of the patient;
Identification of the product involved;
Lot number of the product involved;
Availability of the product involved;
All the indications the user considers useful in order to understand the origin of
the elements of dissatisfaction.
SORIN GROUP ITALIA reserves the right to authorize, if necessary, recall of the
product involved in the notification for assessment. If the product to be returned is
contaminated, it must be treated, packed and handled in conformity with the provisions
of the legislation in force in the country where the product was used.
It is the responsibility of the health care institution to adequately prepare and
identify the product for return shipment. Do not return products that have been
exposed to blood borne infectious diseases.
ONLY for US customers
If for any reason the product must be returned to the manufacturer, a returned good
authorisation (RGA) number is required from Sorin Group USA, Inc. prior to shipping If
the product has been in contact with blood or blood fluids, it must be thoroughly
cleaned and disinfected before packing. It should be shipped in either the original
carton or an equivalent carton to prevent damage during shipment, and it should be
properly labelled with an RGA number and an indication of the biohazardous nature of
the content in the shipment.
The shipping address for returned goods in the US is:
SORIN GROUP USA, Inc.
Returned CV Products
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031
LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the