Contraindications - Fresenius Medical Care multiFiltratePRO Mode D'emploi

multiFiltratePRO
INSTRUCTIONS FOR USE
Please read the following instructions carefully.
GENERAL INFORMATION
General description of the product
The multiFiltratePRO tubings are intended to be used and compatible
with an extracorporeal blood purification system multiFiltratePRO
device.
The multiIFiltratePRO tubings are intended for single use.
The multiFiltratePRO tubings are designed to provide extracorporeal
blood treatment of patients suffering from renal insufficiency.
multiFiltratePRO tubings are composed of the arterial line / access
line (RED line), venous line / return line (BLUE line), filtrate line
(YELLOW line), dialysate line (GREEN line), substituate line / plasma
line (WHITE line) and citrate line (as anticoagulant), calcium line and
heparin line (as anticoagulant).
The variants of multiFiltratePRO tubings are:
• multiFiltratePRO Ci-Ca HDF
• multiFiltratePRO Ci-Ca HD
• multiFiltratePRO HDF
• multiFiltratePRO TPE
• multiFiltratePRO SecuCas Ci-Ca HD
• multiFiltratePRO SecuCas Ci-Ca HDF
multiFIltratePRO tubings can be used in combination with ILA activve
Medical Device.
The multiFiltratePRO tubings are pyrogen free.
Sterilization
The multiFiltratePRO tubing are ethylene oxide sterilized (EO).
COMPOSITION
Tubes: medical-grade soft PVC.
Connectors and other components: Acrylonitrile butadiene styrene
(ABS), Polybutylene Terephthalate (PBT), Polycarbonate (PC),
Polyamide (PA), Polyethylene (PE), Polyethylene Terephthalate
Glycol-modified (PETG), Polypropylene (PP), Polytetrafluoroethylene
(PTFE), Polyvinylchloride (PVC), Silicone, Polyhydroxy Ether
(PHE), Thermoplastic Elastomer (TPE), Polyethylene High-Density
(PEHD), Methyl Methacrylate Acrylonitrile Butadiene Styrene
(MABS), Hydrophobic Acrylic—Polymethyl Methacrylate—(PMMA),
Polyethylene Low-Density (PELD), Polyethylene Terephthalate (PET).
INTENDED PURPOSE AND RELATED DEFINITIONS
Intended purpose
Channeling of blood and fluid in an extracorporeal treatment.
Medical indication
- Acute kidney injury requiring continuous renal replacement therapy
- Volume overload requiring continuous renal replacement therapy
- Intoxications requiring continuous renal replacement therapy
- Conditions requiring the exchange of blood plasma via TPE
- Conditions requiring CRRT combined with hemoperfusion to elimi-
nate further pathogens from blood
- Conditions requiring CRRT combined with ECCO2R for additional
CO2 removal
Intended patient population
The devices have been specified by the manufacturer for the purpose
of treating patients with a body weight of 40 kg and more, irrespec-
tive of their age, under consideration of the specified technical data
of the device and the single-use items used (e.g. delivery rates, fill
volumes).
Intended user group and intended environment
The disposable must only be used by individuals with the appropriate
training, knowledge, and experience on the proper operation and
handling and for whom proof of instruction can be shown.
Operate in rooms suitable for dialysis located in professional health-
care facilities.
Normative and local regulations must be observed.
SIDE EFFECTS
Occasional occurrence of the following side effects is reported in
current literature:
- Hypotension
- Blood loss (e.g. hypovolemia, and hypovolaemic shock, hypoten-
sion, anaemia, cardiac arrhythmia, cardiac arrest)
- Coagulation disorders (e.g. thrombocytopenia)
- Embolism (air-, thrombo-)
- Bacterial infection
- Hypothermia
- Haemolysis
- Hypersensitivity or hypersensitivity-like reactions (e.g. dyspnoea,
cardiopulmonary arrest, hypotension, urticaria, flushing, itching,
abdominal pain, nausea, convulsions and unconsciousness).
Additional side effects might be specific to other devices and drugs
used in the therapy.
Refer to the Instructions for Use of the multiFiltratePRO device for
more information on treatment related side effects.
Reporting of serious incidents
If any serious incident occurs in relation to the device, including those
not listed in this leaflet, the treating physician shall be informed imme-
diately. Within the EU the user must report any serious incident that
has occurred in relation to the device to the manufacturer according to
labelling ( ) and the competent authority of the EU Member State in
which the treatment is performed.
A serious incident can be any incident that directly or indirectly leads
to the death of a patient, user or other person; to the temporary or
permanent serious deterioration of a patient's, user's or other per-
son's state of health; or a serious public health treat.

CONTRAINDICATIONS

Product related contraindications
Hypersensitivity to any of the material of the tubings as listed under
composition or to ethylene oxide residues.
In severe cases the treatment must be discontinued, the blood should
not be returned to the patient, and appropriate emergency medical
treatment should be initiated.
Therapy related contraindication
Refer to the Instructions for Use of the multiFiltratePRO device for
more information of general contraindications for extracorporeal blood
purification.
PERFORMANCE CHARACTERISTICS
Refer to the Instructions for Use of the multiFiltratePRO device for
essential performance parameters.
METHOD OF ADMINISTRATION
Handling Instructions
Refer to the Instructions for Use of the multiFiltratePRO device of the
regarding how to handle the disposable during set-up (e.g. selection
of treatment type), priming, treatment and reinfusion. Also, the Instruc-
tions for Use of other disposables such as the haemofilter must be
taken into account.
Preparation
• Refer to the Instructions for Use of the multiFiltratePRO device for
details on any preparatory handling of the disposable before it is
ready for use or during its use and information to verify if the dispos-
able is properly installed.
• The multiFiltratePRO tubings are intended to be used and compat-
ible with multiFiltratePRO device (refer to label) and shall be used
only after appropriate instruction or training.
• The infusion administration lines should be clamped, except when
needed.
• Unpack and connect the multiFiltratePRO tubings aseptically without
touching open connectors.
• Colour codes should be followed and used in line with the cor-
responding markings on the device.
• Handle pumps and pump clips in accordance to the Instructions for
Use of the device.
• Tighten all closure caps and ensure that all connectors and caps
are secured.
• Fill and rinse the disposable in accordance with the Instructions for
Use of the device or supplemental Instructions for Use for additional
options, and training, if applicable.
• Fresenius Medical Care disposable is designed to withstand the
maximum and minimum manufacturer's recommended pressures
and flow rates generated in use with the respective multiFiltratePRO
device. All the other relevant specifications for the device apply.
Treatment
• In cases where the extracorporeal volume of the circuit consists of a
significant amount of the patient's circulating blood volume, as well as
in anaemic and/or haemodynamically unstable patients, priming the
circuit with blood or blood substitution fluid may be considered.
• To ensure correct functionality of the bubble catchers, fill to about
1 cm below the top. This avoids fluid contacting the hydrophobic filter
as well as air entering the extracorporeal circuit. In the event that fluid
reaches and comes into contact with the hydrophobic filter within the
Transducer Protector (TP) the disposable must be replaced.
• The disposable has an additional connection intended to be con-
nected to the pressure measurement system. This can be used to
connect a new pressure measurement line (available as an accessory
in the Fresenius Medical Care product range).
• Do not push back the fluid in the pressure measurement line by
using a syringe. This might damage the membrane in the TP and
thus lead to contamination. In the event that fluid might have passed
through the TP, check the device for contamination after treatment is
completed. If contamination has occurred, the device must be taken
out of service and disinfected according to the manufacturer's recom-
mendations before further use.
• After the manipulation of lines or the usage of components during
the treatment check and, if necessary, restore the correct position of
the lines and components.
• Disinfect the corresponding access sites without protection cap prior
to connection with other products.
Reinfusion
• Refer to the Instructions for Use of the multiFiltratePRO device for
the termination of the treatment and also to the "Disposal" Section of
the present Instructions for Use.
• Close all clamps on the multiFiltratePRO tubings before removing
the disposable to reduce the risk of fluid leakage.
WARNINGS AND PRECAUTIONS
Warnings
• The disposable must only be used by individuals with the appro-
priate training, knowledge, and experience on the proper operation
and handling and for whom proof of instruction can be shown.
• The multiFiltratePRO tubings are intended for single use only. The
correct function of all interfaces is ensured only for single use. Re-
use may be hazardous to both patient and operator (e.g. impaired
performances, contamination).
• Do not use after use-by date (refer to label).
• If the carton is damaged, check the contained products carefully.
Do not use if the sterile package is damaged, if the protective or
closure caps are not in place or if there is any visible damage on the
finished products (e.g. kinked tubes).
• Make sure that all tubes and chambers are correctly inserted into
the respective holders. Avoid kinking or occluding the disposable in
order to avoid mechanical and chemical damage to cellular blood
constituents.
• For hygienic and functional reasons, it is recommended that
tubing systems are inserted immediately before preparation only,
thereby keeping the preparation and circulation times nearer the
commencement of the treatment and in compliance with applicable
guidelines.
• Connect the multiFiltratePRO tubings aseptically without touching
open connectors.
• Disinfect with 70% alcohol access sites without protection cap
prior to the connection with other products to reduce the risk of in-
fection and let it dry before the connection.
• The compatibility of disinfectants (other than those recommend-
ed) with access sites shall be determined prior to clinical use.
• Excessive negative pressure may cause partial collapse of the
pump segment resulting in an actual blood flow substantially less
than indicated on the device.
• Minimum temperature of use of the disposable is 18°C (64°F).
• To ensure a secure connection between patient access and blood
lines, hold and screw the coloured (blue, red) coupling nut on the
blood line only. Do not apply the screwing torque to the inner part of
the connector. After the connection, check that the components are
firmly screwed together.
• Make sure that the components/tubes in direct interface with the
device fit properly, and ensure that all caps and all screw-lock joints
are secure and properly tightened (particularly those of the patient
connections, the dialyzer connections, the device and the solution
bags connections).
• Inspect the disposable for kinking and leaks during the priming
and treatment phase and take corrective measures (e.g. tightening
Luer-Lock connection) or exchanging it as necessary.
• To avoid air embolism, make sure that the return patient line is
correctly inserted into the device's air bubble detector.
• Careful attention must be given to the installation and blood level
of the bubble catchers. Make sure that due to pressure fluctuation
neither the blood contacts the hydrophobic filter nor air enters the
extracorporeal circuit.
• Change the disposable if a visible clot formation („white strip") is
seen in the blood line downstream of the return line bubble catcher,
for instance at the point where the calcium infusion line merges into
the blood line.
• Cleansing solutions and disinfectants may damage materials em-
ployed for the disposable. Safety and performance of use can no
longer be guaranteed, and the manufacturer assumes no liability.
• The plastics used can be incompatible with drugs or disinfectants
(e.g. connectors made of polycarbonate can develop cracks when
in contact with aqueous solutions with pH > 10).
• If nutritional solutions are administered into the blood line, wet-
ting of the luer-lock connection to the feeding system with lipidic
fluids can weaken the properties of the plastic material used. Make
sure that during the connection of the feeding system, the infusion
line close to the luer-lock connection site remains completely free
of nutrition solution.
Warnings: injection sites
• Do not use needles with a bevelled tip and a diameter larger than
20 gauge (outer needle diameter to be 0.9 mm or less) to puncture
injection sites (if present).
Warnings: needle-free access sites
• Needleless access sites are labelled with the following:
• Use a Luer lock syringe to activate the needle-free access site.
Do not use sharp needles to puncture the needle-free access site
septum. Their use can lead to leaks or air entering the fluid pathway.
Refer to the warning labels present on the finished product.
• Do not connect the syringe used for the needle-free access site
to other parts of the finished product — if the syringe comes into
contact with lubricant, it could become disconnected and lead to
patient injury or death.
Operating time
• The maximum application time is 72 hours. The disposable
must be replaced after the maximum usage time or respec-
tively after a specific blood volume pumped as indicated on the
primary packaging.
Particular notes on materials and substances
CMR substances and endocrine-disrupting substances
For SVHC information according to Article 33 of Regulation
(EC) No. 1907/2006 ("REACH") please use this page: www.
freseniusmedicalcare.com/en/svhc.
Special precautions for storage
Follow the indication of the product label. Protect from moisture,
freezing and excessive heat.
Disposal
Ensure safe disposal of any unused product or waste material in
accordance with local regulations.
Materials that have been in contact with blood or other material of
human origin may be infectious. Dispose of such materials by taking
the necessary precautionary measures and in accordance with local
regulations for (potentially) infectious materials.
SYMBOLS USED ON LABELS
Medical Device
Unique Device Identifier
Patient information website
Latex-free
LATEX
EO Fluid pathway sterile.
Sterilized using ethylene oxyde
Replace the Blood line after maximum usage time or
M M A A X X
pumped blood volume as indicated on the primary
T T I I M M E E / /
V V O O L L U U M M E E package
Pump segment diameter/ length
Blood Priming Volume
Units
30°C
Temperature limit
5°C
Do not use if package is damaged
Sterile barrier system
SBS
WARRANTY
The manufacturer shall not be liable for any misuse, improper handling,
non-compliance with instructions for use and cautionary notes, and for
any damage incurred subsequent to the manufacturer's delivery of the
multiFiltratePRO tubings.
DATE OF REVISION OF TEXT
11/2021
A digital version of this document is available on the following website:
www.freseniusmedicalcare.com/en/product-information.
INFORMATION ON THE MANUFACTURER
Legal manufacturer
Fresenius Medical Care AG & Co. KGaA
Else-Kröner-Str. 1, 61352 Bad Homburg
GERMANY +49 6172 609-0
www.freseniusmedicalcare.com/en/product-information
en
0123