baxter prismaflex TPE1000 SET Notice D'utilisation page 15

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014992
Designer: CDS
Colour Reference:
BLACK
20. Destroy this set after single use, using aseptic technique for potentially
contaminated equipment. Do not resterilize. The Prismaflex TPE 1000/ TPE
2000 set is intended for single use only. Re-using the Prismaflex TPE 1000/
TPE 2000 set may cause serious damage to the product resulting in patient
injury or death.
21. Use only drugs compatible with plastics listed in the specifications section.
Some plastics can be incompatible with drugs when in contact with solutions
with pH > 10.
* Influence of Different Heparin Concentrations on the results of In Vitro
Investigations in Plasma separation technology using Capillary Membrane Filters.
J.K.Unger, C.Haltern... Artificial Organs 2003;27(7):649-647
SPECIFICATIONS
See Tables at end of document.
SET MATERIALS
Plasmafilter hollow fiber : Polypropylene
Housing and headers : Polycarbonate
Potting compound : Polyurethane
Tubing material : Plasticized polyvinyl chloride (PVC)
Cartridge : Polyethyleneterephtalate Glycol
Note: the following information is available from the manufacturer upon request:
• information about test methods used to obtain performance characteristics,
• the number and range of particles in the effluent from the dialyzer prepared
as recommended for clinical use,
• the types and amounts of residue from the sterilization process.
Note: the Prismaflex set is not made with natural rubber latex.
Note: all fluid pathways in direct or indirect blood contact are DEHP-free
Pressure monitoring in Prismaflex TPE : definitions and purpose
* access transmembrane pressure: TMPa = PA-PF
TMPa is the local transmembrane pressure at the filter inlet and matches with the
maximum local transmembrane pressure along the filter. It is used to predict risk
of hemolysis, as hemolysis is associated with a threshold value in local filtration
flux (<=> pressure gradient).
** transmembrane pressure : TMP = (PA+PO)/2-PF
This parameter represents the average pressure gradient across the membrane
when linear blood and filtrate pressure drops are assumed. It allows to predict the
filtrate flow rate.
(PA = filter inlet pressure (blood inlet side), PO = filter outlet pressure (blood return
side), PF = filtrate pressure).
INSTRUCTIONS FOR USE
Note: use the set by following the detailed on-line instructions provided by the
control unit. Additional information is available in the control unit operator's
manual.
Load Set
Install the set onto the control unit using the photographs on the inside cover as
a guide - the same procedure applies for both PrismaFlex and PrisMax control
units (in countries where PrisMax is cleared or registered).
Prepare and Connect Solutions
Hang bag of priming solution saline or alkaline solution (pH >= 7.3) with or without
heparin added (5000IU heparin/liter, correctly homogenised) according to usual
institutional practice, on priming hook. Connect access (red)/effluent (yellow)
Y-line to priming solution bag.
SPECIAL PROCEDURES IN CASE
OF COMPLICATION
External Blood Leaks
Note: see Warning no. 16.
If an external blood leakage is observed, immediately stop the blood pump. Initiate
corrective action by securing connections or replacing the Prismaflex set.
If necessary, administer adequate replacement solution to the patient to
compensate for blood loss.
Date: 02-NOV-2020 Proofread No.: 1
Page: 15 of 80
Hypersensitivity Reactions
Note: see Warning no. 14.
Should acute allergic reactions (first use syndrome) occur within the first few
minutes of the treatment, it is important to react immediately by discontinuing the
session and administering appropriate treatment.
Therefore, the prescribing physician must pay special attention to patients
receiving ACE inhibitors and/or having already shown similar reactions.
Hemolysis
Note: see Warnings no. 18 and 19.
During TPE therapy, the risk of hemolysis exists due to the relatively large pore
size of the membrane and the pressure difference needed between the blood and
the effluent sides of the plasmafilter. The combination of a low blood flow rate and
a high replacement flow rate (and or a high patient plasma loss flow rate) increases
the risk of hemolysis by causing an excessive TMPa (access transmembrane
pressure). To minimize the risk of hemolysis, the control unit monitors the TMPa
and issues alarms if maximum pressure limits are exceeded.
In some cases hemolysis may occur and not be detected by a control unit alarm,
however, a pink or red tinge may appear in the effluent bag. Therefore, while
performing TPE therapy, monitor the effluent bag closely. In case of suspected
hemolysis, immediately reduce the replacement and plasma loss flow rates to zero
and verify patient's parameters before proceeding with treatment.
WARRANTY AND LIMITATION OF LIABILITY
a) The manufacturer warrants that the Prismaflex set has been manufactured in
accordance with its specifications and in compliance with good manufacturing
practices, other applicable industry standards and regulatory requirements.
If provided with the lot/serial number of the defective product, the manufacturer
will, by replacement or credit, remedy manufacturing defects in the Prismaflex
set becoming apparent before the expiration date.
b) The warranty under paragraph a) above is in lieu of, and to the exclusion of,
any other warranty, whether written or oral, express or implied, statutory or
otherwise, and there are no warranties of merchantability or other warranties,
which extend beyond those described in paragraph a) above. The remedy set
out above for manufacturing defects is the sole remedy available to any person
due to defects in the Prismaflex set and the manufacturer shall not be liable
for any consequential or incidental loss, damage, injury or expense arising
directly or indirectly from the use of the Prismaflex set, whether as a result of
any defect therein or otherwise.
c) The manufacturer shall not be liable for any misuse, improper handling, non-
compliance with warnings and instructions, damage arising from events after
the manufacturer's release of the Prismaflex set, failure or omission to inspect
the Prismaflex set before use in order to ensure that the Prismaflex set is in
proper condition, or any warranty given by independent distributors or dealers.
d) The manufacturer is GAMBRO Industries, 7 avenue Lionel Terray, BP 126,
69883 MEYZIEU CEDEX, FRANCE.
Philippines:
Baxter Healthcare Philippines Inc., Silangan Industrial Estate, Brgy. Canlubang,
Calamba City, Laguna, Philippines
MDR-07360
Malaysia:
Authorized Representative: Baxter Healthcare (Malaysia) Sdn. Bhd.
B-21-3A, Level 21, The Ascent,
Paradigm, No. 1, Jalan SS7/26A,
Kelana Jaya, 47301 Petaling Jaya,
Selangor Darul Ehsan, Malaysia
Registration number: GC42859853918
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