Special Procedures In Case Of Complication - baxter Prismaflex ST60 SET Gebrauchsanweisung

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014988
Designer: DEP
Colour Reference:
BLACK
16. To assure adequate filter performance, it is recommended that the set be
changed every 24 hours of use. However, the set must be changed after 3
days (72 hours). Continued use beyond this limit could result in rupture of the
pump segments, with risk of patient injury or death.
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 end of document.
SET MATERIALS
AN69 ST hollow fiber : Acrylonitrile and sodium methallyl sulfonate copolymer
+ Polyethylene Imine (surface treatment agent)
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 rubber natural 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
In order to gain full benefit from the AN69ST in terms of improvement of
hemocompatibility, it is recommended to add 5000IU of unfractionated heparin
per liter of priming/rinsing solution. This procedure allows the adsorption of active
heparin onto the AN69ST before the start of extracorporeal circulation.
Consequently, the systemic anticoagulation strategy during treatment will be
adapted with respect to patient specificity. In the cases where priming/rinsing
without addition of unfractionated heparin, we recommend infusing the loading
dose of heparin to the patient 2 to 5 minutes before connection to the filter.
Hang bag of priming solution [saline or alkaline solution (pH ≥ 7.3) with added
5000IU unfractionated heparin/liter according to usual institutional practice,
correctly homogenised] 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. 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.
Date: 07-OCT-2020 Proofread No.: 1
Page: 16 of 96
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.
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.
Patients receiving angiotensin converting enzyme (ACE) inhibitors as medication
can develop, within the first few minutes of a treatment, symptoms similar to
acute allergic reactions i.e bronchospasm, edema of airways or larynx, dyspnea,
angioedema, urticaria, nausea, vomiting, diarrhea, respiratory arrest, abdominal
cramping, hypotension, hypovolemic shock and death.
However, for these patients, administration of antihistamines often does not
alleviate the symptoms. In this case, treatment must be stopped and a more
aggressive first-line therapy for an anaphylactoid reaction should be initiated
immediately after the onset of symptoms.
Therefore, the prescribing physician must pay special attention to patients
receiving ACE inhibitors and/or having already shown similar reactions.
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.
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