Warranty And Limitation Of Liability - baxter prismaflex HF 20 SET Folleto De Utilización

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014990
Designer: CDS
Colour Reference:
BLACK
17. Destroy this set after single use, using aseptic technique for potentially
contaminated equipment and following local regulation for disposal.
Do not re-sterilize. The Prismaflex set is intended for single use only.
Re-using the Prismaflex set may cause serious damage to the product
resulting in patient injury or death.
18. 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.
SPECIFICATIONS
See Tables at the end of the document.
SET MATERIALS
PAES hollow fiber : PolyarylEtherSulfone
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.
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) according to usual institutional practice, on
priming hook. Connect access (red)/effluent (yellow) Y-line to priming solution bag.
Anticoagulation considerations
According to the literature* continuous heparinization at a rate of 10 to 20.IU/kg/h
ensures proper operation of the extracorporeal circuit when performing treatment
with patients having normal coagulation status.
Depending on the patient's condition, however, heparinization can be lowered to
less than 5 IU/kg/h.
Heparinization can be controlled, for instance, by partial thromboplastin time (PTT)
measurements: in this case, PTT could be maintained at 20 to 30 seconds over baseline.
* "Continuous renal replacement therapy in critically ill neonates", G.ZOBEL & Al., Kidney International, Vol.53,
Suppl. 66 (1998).
SPECIAL PROCEDURES
IN CASE OF COMPLICATION
External Blood Leaks
Note: see Warning no. 15.
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.
Hypersensitivity Reactions
Note: see Warning no. 13.
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.
Date: 19-NOV-2020 Proofread No.: 1
Page: 15 of 84
Adverse reactions may occur due to the complex interaction between blood
and the artificial surfaces of the entire extracorporeal circuit. These reactions
may also be precipitated and/or exacerbated by other external factors involved
with the individual patient's specific disease process and the treatment of renal
insufficiency. Certain types of adverse reaction may occur due to operational
factors associated with the treatment. Therefore, proper management of the
fluid removal, electrolyte balance, anticoagulation and blood flow rate as well as
monitoring of the overall treatment parameters are essential to avoid side-effects
which may be associated with hemodialysis/hemofiltration therapies.
Hypersensitivity reactions have been observed during dialysis. Symptoms of a
hypersensitivity reaction may be gastrointestinal, mucocutaneous, respiratory,
cardiovascular or systemic in nature and range from very mild to severe. Such
symptoms have been described as anaphylactic-like reactions within the first
few minutes. Manifestations include nausea, malaise, weakness, a sensation of
burning or heat throughout the body, profuse perspiration, respiratory distress and
in some instances hypotension and cardiopulmonary arrest. Should a combination
of such symptoms appear, particularly at the start of the treatment session, it is
important to react immediately by discontinuing the session and administering
appropriate treatment. Blood in the extracorporeal circuit must not be returned
to the patient.
Extra care must be taken when treating patients who have exhibited possible
hypersensitivity symptoms during previous treatments, or patients who have a
history of being highly sensitive and allergic to a variety of substances. A physician
must be consulted to evaluate the risk and prescribe the appropriate precautions
if a possible sensitivity is suspected.
The following factors are considered essential to minimize the risk of hypersensitivity
reaction and other side effects:
• Strict adherence to the set-up, priming and rinsing procedures detailed in the
manufacturer's instructions for use.
• Setting up and monitoring the treatment operating parameters according to the
manufacturer's recommendations specified for each type of Prismaflex set and
to the patient's needs and tolerance.
• Strict adherence to all WARNINGS and CAUTIONS given by the manufacturer in
the instructions for use.

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.
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: GC25696881418
PHILIPPINES:
Imported and distributed by Baxter Healthcare Philippines, Inc.
Silangan Industrial Estate, Brgy. Canlubang, Calamba City, Laguna, Philippines
MDR-01243
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