CERUS INTERCEPT Manual Del Usuario página 3

For use with INTERCEPT Illuminator
Each set is wrapped in a tamper-evident package and includes one 15mL 6mM amotosalen
hydrochloride solution container (Formula : Amotosalen HCl 203mg - Natr. chlorid. 924mg
- Aqua ad iniect. ad 100mL), one illumination container,
one compound adsorption device (CAD), three INTERCEPT Plasma storage containers.
The set is sterilized by a combination of steam and radiation.
Indications and Usage
This set is used with an INTERCEPT Illuminator to inactivate a broad spectrum of viruses,
bacteria, parasites as well as contaminating donor leukocytes in plasma. INTERCEPT
plasma is indicated for support of patients requiring plasma transfusions, according to
clinical practice guidelines. INTERCEPT plasma may be stored from the time of collection
for 12 months between -18°C and -25°C or for 24 months below -25°C, in compliance with
applicable procedures and regulations.
Contraindications
Use of INTERCEPT Plasma is contraindicated in patients with a history of allergic
response to amotosalen or psoralens.
Precautions
Do not use if: tamper-evident package has been opened; signs of deterioration are visible;
fluid path closures are loose or not intact; cannulae are broken or there is no fluid in
amotosalen solution container.
Do not store above 25°C. Do not vent. Do not freeze. Protect the pack and tubing from
sharp objects.
Unused sets in open aluminium foil may be kept 20 days at room temperature by folding
and securing open end of aluminium foil. Units removed from the aluminium foil must be
used within 24 hours.
Keep set in light-protective package until time of use. Protect from direct sunlight and
strong UVA light source.
Set is single use only. Do not reuse. Do not resterilize. This product is not designed for
reuse. Misuse can result in adverse reactions, including severe illness and possibly death.
All the following conditions must be met for pathogen inactivation:
- Plasma volume and red blood cell (RBC) content must be within the range specified in
Table 1.
- Plasma mixed with amotosalen must be exposed to UVA light dose from INTERCEPT
Illuminator. No other source of UVA light may be used.
- Plasma must be passed through the CAD by gravity flow process after illumination.
- For fresh plasma. the entire process from collection to freezing must be completed within
a timeframe of 20 hours or according to local regulations.
- Fresh frozen plasma that has been thawed in accordance with local regulations must be
immediately treated with the INTERCEPT Blood System for plasma and transfused or
refrozen promptly after treatment.
This process is designed to be a closed system. Treatment with INTERCEPT Blood
System does not replace applicable standards for processing in open and closed systems.
If there is a leak in the set during processing, plasma product must be discarded.
Warnings : Amotosalen in contact with skin may result in photosensitisation in the presence
of ultraviolet light. If skin exposure occurs, flush exposed skin copiously with water. Sterile
connecting device (SCD) should be used according to manufacturer's instructions for use.
Notes to Physicians
While laboratory studies of amotosalen processing with UVA light have shown a reduction
in levels of certain viruses, bacteria and parasites; there is no pathogen inactivation
process that has been shown to eliminate all pathogens.
Neonatal patients who require plasma transfusion during phototherapy for treatment of
hyperbilirubinemia should not be treated with phototherapy devices that emit light less
than 425nm to avoid the theoretical potentiation of erythema resulting from interaction
between UVA light and psoralen.
Instructions for Use
Materials Needed: One (1) INTERCEPT Processing Set for Plasma.
Equipment Needed: INTERCEPT Illuminator, Sterile Connecting Device (SCD), Tube
Sealer.
Temperatures should be controlled to meet applicable regulations for plasma processing.
Used and unused INTERCEPT sets should be discarded like any used blood containers,
as biohazardous waste.
Process Steps
A-Plasma for Processing with the INTERCEPT Blood System
Plasma products within the following ranges have been shown to be acceptable for use
with this processing set.
Volume
385-650 mL
INTERCEPT PROCESSING SET for PLASMA
Table 1
RBC content
<4 × 10 RBC/mL
6
B- Amotosalen Addition
1. Remove set from package.
2. Weld tubing from plasma container to amotosalen container tubing using SCD.
3. Disassemble set from organizer and remove rubber band.
4. If two plasma units will be produced by the INTERCEPT process, heat seal and
remove one storage container.
5. Label set containers using appropriate donation identification. See warning in section
C. While labeling storage containers, separate them to ensure they do not adhere to
one another.
6. Hang plasma container. ensuring that set containers/components do not come in
contact with floor. Break both cannulae on amotosalen container.
7. Allow plasma and amotosalen solution to flow into illumination container marked by
number "1".
8. Ensure that plasma drains completely from initial plasma container into illumination
container.
9. Express air from the illumination container into the amotosalen container.
10. When air is removed and plasma has fully drained back into the illumination container,
mix illumination container thoroughly by gentle agitation to ensure complete mixing of
amotosalen and plasma.
11. Express a small amount of plasma and amotosalen mixture into tubing, filling at least
4cm of tubing.
12. Seal tubing between illumination container and amotosalen container within the 4cm.
Warning : During illumination, tubing must be held within large compartment of
illumination tray.
13. Remove and discard initial plasma container, amotosalen container and excess tubing.
C- Illumination
Illuminate plasma.
Refer to INTERCEPT Illuminator Operator's Manual for complete illumination instructions
for use. Warning : All plasma, both in illumination container and tubing, must be within large
compartment of illuminator tray in order for inactivation to occur. The process requires
unimpeded light transmission through tray and illumination container with plasma. No
labels or other material should be on this area. Tray must be clean. Labels should be
placed on illumination container flap only. Illumination container should lay flat.
D- Processing with Compound Adsorption Device (CAD)
1. Hang illumination container, allowing CAD to hang freely, with storage containers kept
in an inverted position.
2. Close clamp on bypass line; ensure all other clamps are open.
3. Break cannula on illumination container and allow plasma to flow through CAD marked
with the number "2" into storage containers marked with the number "3".
4. Once plasma has emptied from illumination container and passed through CAD, close
clamp on tubing leading from the CAD and open clamp on the bypass line.
5. Hang CAD together with illumination container.
6. Remove storage containers from tab on CAD and allow them to hang ports up.
7. Completely express air from storage containers through bypass line.
8. Close clamp on the bypass line and open the clamps on storage containers.
9. Open clamp below the CAD, allowing plasma to drain into storage containers.
10. Ensure that the storage container tubing contains plasma and no air. Close clamps on
storage containers.
11. Re-distribute plasma volume between storage containers, if necessary.
12. Ensure appropriate donor identification is attached to each filled plasma storage
container.
13. Disconnect storage containers from set by heat-sealing, allowing sufficient tubing
length for segments.
14. Discard CAD and illumination container. The INTERCEPT Plasma process is now
complete.
15. Seal tubing as appropriate for making segments as needed.
16. Follow internal procedures for freezing plasma.
Caution: DEHP is known to be released from polyvinyl chloride (PVC) medical devices;
increased leaching can occur with extended storage or increased surface area contact.
The INTERCEPT processing sets only have tubing components, container ports and,
if included, an in-line filter that contain PVC; all containers and other parts are PVC-
free. During use of this processing set, blood components are in contact with PVC for
a brief period of time (approx. <15 minutes). Based on limited surface area contact and
minimal contact time, DEHP levels in blood components after use of the processing set
are estimated to be well below those resulting from other medical applications containing
PVC tubing (e.g. hemodialysis, intravenous fluid administration, extracorporeal membrane
oxygenation and cardiopulmonary bypass procedures). The risks associated with DEHP
released to the blood components must be weighed against the benefits of therapeutic
transfusion and inactivation of harmful viruses, bacteria and other pathogens.
Cerus, INTERCEPT, and INTERCEPT Blood System are trademarks of Cerus Corporation
en - English
28-59-01-104
ver. 2014-02