General Information; Contraindications; Directions For Use - baxter THERANOVA 400 Notice D'utilisation

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: N50 648 rev 007
Designer: DEP
Black
Colour Reference:
Indications for use
THERANOVA dialyzers are indicated for treatment of chronic and acute
renal failure by Hemodialysis.
Explanation of non-harmonized symbols:
HDF
CAUTION! Do not use THERANOVA dialyzers for
HDF (hemodiafiltration) or HF ( hemofiltration) due to
higher permeability of larger molecular weight proteins
such as albumin.
Description of the device
Device with sterile and non-pyrogenic fluid pathways. See specification
table.
Expanded hemodialysis, enabled by the Theranova dialyzer, expands the
range of uremic solutes (up to 45 000 Da) efficiently removed during inter-
mittent hemodialysis.
The Theranova dialyzer provides removal of small molecules (<500 Da,
such as urea) equivalent to high flux membranes used in hemodialysis (HD)
and hemodiafiltration (HDF). Removal of conventional middle molecules
(500 - <25 000 Da, such as κ-Free Light Chains) is increased compared to
high flux membranes used in HD. Removal of large middle molecules (25
000- 45 000 Da, such as λ-Free Light Chains) is increased compared to
high flux membranes used in HD and HDF.
Expanded hemodialysis, enabled by the Theranova dialyzer, achieves its
performance using existing hemodialysis workflow, and infrastructure [1,2].
Theranova is not to be used for hemodiafiltration.
[1] Kirsch AH, et al. Performance of hemodialysis with novel medium cut-off
dialyzers. Nephrol Dial Transplant 2017; 32(1):165-72. [2] Weiner et al.
Efficacy and Safety of Expanded Hemodialysis with the Theranova 400
Dialyzer. A Randomized Controlled Trial. Clin J Am Soc Nephrol 2020;15
(9) 1310-1319

Contraindications

There are no known contraindications for the use of the dialyzers.
Definition of Expressions
used in this manual
WARNING! is used to alert the operator not to take a specific action that can
cause potential hazard which, if ignored, can result in an adverse reaction,
injury or death.
CAUTION! is used to alert the operator to take a specific action to protect
against a possible hazard which, if ignored, could have an adverse effect
on the patient or equipment.
NOTE! is used to remind the operator of normal treatment functions and
what is the suitable action in a particular situation.
General Warnings and Cautions
The dialyzers are for single use only. The quality of the product is guaran-
teed for first use only, and only when prepared and used according to
the procedures described. Reprocessing this dialyzer may cause serious
damage to the product resulting in patient hazard.
Set-up instructions
WARNING! Do not use if package or product is damaged or if protection
caps are not in place.
WARNING! Aseptic technique is required throughout dialysis preparations
and treatment to avoid contamination.
WARNING! For automated priming modes please refer to the clinic's
protocol and the operator's manual of the dialysis equipment in use.
Recommendations for manual priming:
• Prepare and connect a bag with isotonic saline (e.g. 0.5 l) to the blood lines.
• Remove the protective caps from the blood ports and use them to close the
dialysate ports.
• Position the filter vertically and connect the blood lines to the filter to fill up
the blood compartment from bottom to top.
• Start the blood pump at 100 ml/min.
• Prime the circuit with ≥ 300 mL isotonic saline.
WARNING! Eliminate as much air as possible from the blood compartment.
• Attach the dialysate tubing for counter current flow.
• Activate the dialysate flow and remove air from the dialysate compartment
of the dialyzer.
• The dialyzer is now ready for connecting to the patient!
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Date: 22-FEB-2021 Proofread No.: 01
Page: 6 of 24
Material Specification: HEC1129061

General Information

WARNING! Treatment parameters should be chosen within the limitations
given in the specification table.
WARNING! Use the dialyzers only with dialysis equipment which can
accurately control and monitor the ultrafiltration rate, and blood in the
dialysate circuit (blood leak detector).
WARNING! Expanded removal of molecules may lead to increased
removal of certain drugs. Clinicians should consider this when prescribing
the device and make any necessary dosing adjustments.
CAUTION! Federal law (USA) restricts this device to sale by or on the order
of a physician.
CAUTION! Do not apply isolated/sequential ultrafiltration when using
THERANOVA dialyzers, due to higher permeability for larger plasma proteins
such as free haemoglobin. In dialysis patients plasma free haemoglobin
is usually present in low concentrations (up to 239 mg/L [3]). During
isolated/sequential ultrafiltration free haemoglobin is filtered and concen-
trated in the dialysate compartment. This leads to a reddish coloration of
the ultrafiltrate which may trigger the internal blood leak detector. [3] Meyer
et al., Hemodialysis-induced release of hemoglobin limits nitric oxide
bioavailability and impairs vascular function, J Am Coll Cardiol. 2010 Feb.
2;55(5):454-9
Adverse events
Certain types of adverse reactions may occur due to operational factors
associated with the treatment
WARNING! Selection of a suitable dialyzer configuration and of treatment
parameters should be considered based on patient characteristics (body
size, weight, cardiovascular status, therapy tolerance etc.) and clinical
requirements.
WARNING! Adherence to set-up and priming procedures, proper
management of fluid removal, electrolyte balance, adjustment of the
pH-value of the dialysate, anticoagulation, blood and dialysate flow rates
as well as monitoring of the overall treatment parameters are essential to
avoid side effects which may be associated with Hemodialysis.
WARNING! To minimize bacterial and endotoxin contamination, com-
pliance to water and dialysate quality standards such as ANSI/AAMI
RD62 or ISO 23500 series should be monitored.
In rare cases (e.g. for patients having a history of being highly sensitive
to a variety of substances), hypersensitivity reactions may occur during
dialysis, particularly at the onset of treatment. In severe cases, dialysis
must be discontinued and appropriate medical intervention administered.
After priming the dialysate compartment the fluid in the blood compart-
ment may contain bicarbonate. During patient connection the volume and
rate of infusion of this fluid needs to be considered, especially for pati-
ents with metabolic acidosis. Discard as much as possible of the priming
solution.
Clinical side effects
If an internal blood leak is observed, the operator must stop the treat-
ment session and replace the dialyzer. Do not return the blood to the
patient since it may have become contaminated by the dialysis fluid. If
necessary, administer adequate replacement solution to the patient to
compensate for the blood loss.
WARNING! If an external blood leak is observed, secure connections
or replace the dialyzer. If necessary, administer adequate replacement
solution to the patient to compensate for the blood loss.

Directions for Use

Treatment instructions
• Follow instructions in the operator's manual of the dialysis equipment in use.
CAUTION! Anticoagulation is recommended to prevent clotting in the
extracorporeal circuit. Anticoagulation therapy should be selected adjusted
to the needs of the patient and monitored under the direction of a physician.
If Heparin is used, it is recommended to administer a loading dose to the
patient 2 to 5 minutes before start of the treatment.
• Connect the arterial blood line to the vascular access of the patient.
• Connect the venous line to the vascular access of the patient.
• Start the blood pump and increase the blood flow rate to the
prescribed value.
To avoid haemoconcentration in the dialyzer, do not start ultrafiltration
before desired blood flow rate is reached.
WARNING! If a dialysate compartment leak is observed the operator
has to check the correct placement of the dialysate connectors or to stop
the treatment and replace the dialyzer. If necessary, administer adequate
replacement solution to the patient to compensate fluid imbalance.
WARNING! If air enters the extracorporeal blood circuit, an air
embolism may occur. This can be hazardous to the patient. To minimize
the risk of air embolism constant monitoring of the extracorporeal blood
circuit, both visually and with an air detector, is recommended. Strict
adherence to the manufacturer's recommended activities will facilitate
the removal and prevent the accumulation of air in the dialyzer before
the treatment session. If air enters or is identified in the dialyzer during
priming and cannot be removed with the use of additional priming, the
dialyzer must be replaced.
CAUTION! If clotting occurs in the dialyzer both the dialyzer and the
blood lines must be replaced. Flush the vascular access devices accor-
ding to clinic procedure. Discard the dialyzer and the blood lines. Do not
return the blood to the patient.
Warranty
The manufacturer warrants that the capillary dialyzer has been manu-
factured in accordance with its specifications and in compliance with good
manufacturing practices, other applicable industry standards and regula-
tory requirements.
If provided with the lot number of the defective product, the manu-
facturer will, by replacement or credit, remedy manufacturing defects in the
dialyzer becoming apparent before the expiry date.
Expiry date: Refer to information on the unit container label.
The warranty above is in lieu of, and to the exclusion of, any other warranty,
whether written or oral, expressed or implied, statutory or otherwise, and
there are no warranties of merchantability or fitness or other warranties,
which extend beyond those described.
The remedy set out above for manufacturing defects is the sole remedy
available to any person due to defects in the dialyzer and the manu-
facturer shall not be liable for any consequential or incidental loss,
damage, injury or expense arising directly or indirectly from the use of the
dialyzer, whether as a result of any defect therein or otherwise.
The manufacturer shall not be liable for any misuse, improper hand-
ling, non-compliance with warnings, directions and instructions in the
labeling, damage arising from events after the manufacturer's release
of the dialyzer before use in order to insure that the dialyzer is in proper
condition, or any warranty given by independent distributors or dealers.
Performance Data
Performance data calculated from values measured acc. ISO 8637-1
The performance values given below should be regarded as approximate.
Under clinical conditions, different values may be obtained due to the
clinical settings and measuring technique.
Information about test methods used to obtain performance data is
available from the manufacturer upon request.
PERFORMANCE TABLES SEE SECTION: PERFORMANCES.
Termination of Treatment
• Follow instructions in the operator's manual of the dialysis equipment in use.
• Connect the arterial blood line to a bag of isotonic saline solution and
adjust the blood flow rate to return the blood to the patient.
This does not apply if online-fluid is used for rinse back
(e.g. with Artis and ULTRA prime line).
WARNING! Do not deactivate the air detection system on the machine until
the patient is disconnected.
• When the required amount of blood has been returned to the patient,
stop the blood pump and disconnect the patient.
• Follow the instructions in the operator's manual of the dialysis
equipment in use how to empty and disconnect the dialyzer and blood
lines.
• After use, this product may be a potential hazard. Handle and
dispose of in accordance with accepted medical practice and applicable
local, state and federal laws and regulations.