Device Change-Out; Return Of Used Products - sorin SYNTHESIS R Mode D'emploi

to determine the blood contamination will indicate for how long
the system is suitable for reinfusion of sterile blood.
O. DEVICE CHANGE-OUT
A spare device must always be available during bypass in the
unlikely event that the oxygenator in use requires change-out.
Procedures lasting longer than 6 hours or particular situations where
the safety of the patient may be compromised (insufficient
performance, leaks, abnormal blood parameters etc.), could require
change-out. Follow the steps below to change out the oxygenator.
Use sterile methods during all replacement procedures.
REQUIRED MATERIAL
- 1 SYNTHESIS R venous reservoir code 050233
- 7 tube clamps
- 1 sterile blade
- 1 pair of sterile gloves
1. While the patient is still on bypass, remove the new SYNTHESIS R
reservoir from its outer packaging and from the sterile wrapper;
inspect it for damage.
2. Clamp the venous outlet line of any supplementary cardiotomy
reservoir, disconnect it from SYNTHESIS R and connect it to the
new SYNTHESIS R reservoir.
3. Clamp the suction lines and connect them to the new SYNTHESIS
R reservoir.
4. Remove the defective SYNTHESIS R reservoir from its holder and
replace it with the new one. It is recommended to have someone
hold the defective device.
5. Remove the defective device from the circuit as follows:
- Remove the temperature probe.
- Clamp all the accessory lines and remove them.
- Release the sampling system from its holder and remove it.
- Stop the gas flow.
- Place two clamps (5 cm apart) on the venous inlet line and turn
off the main pump.
- Place one clamp on the arterial outlet line.
- Place two clamps (5 cm apart) on the outlet line.
- Cut the venous return line and the SYNTHESIS R outlet line at
the point lbetween the two clamps and connect them to the new
SYNTHESIS R reservoir.
6. Connect the purge line of the oxygenator gas module to the new
SYNTHESIS R reservoir. Open the purge line.
7. Remove the clamps from the arterial outlet line and venous return
line. Regulate the blood flow and restore suction flow.
8. Adjust the FiO2 to 100% with a 1:1 gas/blood flow ratio.
9. If necessary, add priming solution.
10. Eliminate the air in the blood sampling system.
11. Inspect the unit, its connectors and lines for any leaks and make
certain that the air has been properly vented.
12. Connect the temperature probes and accessory lines as needed.
13. Perform venous and arterial blood gas analyses and measure the
activated clotting time (ACT) to determine the patient status and to
improve the perfusion parameters.
14. Check and strap all the connections.
15. The blood left in the defective SYNTHESIS R unit can be
recovered by connecting the reservoir outlet line to one of the 3/8"
connectors of the new venous reservoir; then drain into the
reservoir from the old unit.
Upon completion of this operation contact Sorin Group Italia or
an authorised representative to analyse the SYNTHESIS R
considered defective.
P. MEDICAL DEVICES FOR USE WITH
SYNTHESIS R
- Linea Set / kits for postoperative chest drainage.
- Synthesis RESERVOIR HOLDER for venous reservoir code
050129.
- Temperature probe (YSI 400 Series compatible)
- Kit for active venous drainage with vacuum, code ID096834
- At present Sorin Group Italia is not aware of any contraindications
for use of the device with occlusive or non-occlusive pumps. The
use of other types of pumps must be agreed with Sorin Group Italia.
Q. 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 the 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;
8
 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 goods 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.
R. LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the
Purchaser pursuant to applicable law.
SORIN GROUP ITALIA warrants that all reasonable care has been
taken in the manufacture of this medical device, as required by the
nature of the device and the use for which the device is intended.
SORIN GROUP ITALIA warrants that the medical device is capable
of functioning as indicated in the current instructions for use when
used in accordance with them by a qualified user and before any
expiry date indicated on the packaging.
However, SORIN GROUP ITALIA cannot guarantee that the user will
use the device correctly, nor that incorrect diagnosis or therapy
and/or that the particular physical and biological characteristics of an
individual patient, do not affect the performance and effectiveness of
the device with damaging consequences for the patient, even though
the specified instructions for use have been respected.
SORIN GROUP ITALIA, whilst emphasizing the need to adhere
strictly to the instructions for use and to adopt all the precautions
necessary for the correct use of the device, cannot assume any
responsibility for
consequences arising directly or indirectly from the improper use of
this device.
SORIN GROUP ITALIA undertakes to replace the medical device in
the event that it is defective at the time of placing on the market or
whilst being shipped by SORIN GROUP ITALIA up to the time of
delivery to the final user unless such defect has been caused by
mishandling by the purchaser.
The above replaces all other warranties explicit or implicit, written or
verbal, including warranties of merchantability and fitness for
purpose. No person, including any representative, agent, dealer,
distributor or intermediary of SORIN GROUP ITALIA or any other
industrial or commercial organization is authorized to make any
representation or warranty concerning this medical device except as
expressly stated herein. SORIN GROUP ITALIA disclaims any
warranty of merchantability and any warranty of fitness for purpose
with regard to this product other than what is expressly stated herein.
The purchaser undertakes to comply with the terms of this Limited
Warranty and in particular agrees, in the event of a dispute or
litigation with SORIN GROUP ITALIA, not to make claims based on
alleged or proven changes or alterations made to this Limited
Warranty by any representative, agent, dealer, distributor or other
intermediary.
The existing relations between the parties to the contract (also in the
case that it is not drawn up in writing) to whom this Warranty is given
as well as every dispute related to it or in any way connected to it as
well as anything related to it or any dispute concerning this Warranty,
its interpretation and execution, nothing excluded and/or reserved,
GB – ENGLISH
any loss, damage, expense, incidents or