CARE AND MAINTENANCE
The care and maintenance of the catheter requires well trained, skilled personnel following a detailed protocol. The protocol should include a
directive that the catheter is not to be used for any purpose other than the prescribed therapy.
ACCESSING CATHETER, CAP CHANGES, DRESSING CHANGES
3
• Experienced personnel
• Use aseptic technique
• Proper hand hygiene
• Clean gloves to access catheter and remove dressing and sterile gloves for dressing changes
• Surgical mask (1 for the patient and 1 for the healthcare professional)
• Catheter exit site should be examined for signs of infection and dressings should be changed at each dialysis treatment.
• Catheter Luer-lock Connectors with end caps attached should be soaked for 3 to 5 minutes in povidone iodine and then allowed to dry
before separation.
• Carefully remove the dressing and inspect the exit site for infl ammation, swelling and tenderness. Notify physician immediately if signs of
infection are present.
EXIT SITE CLEANING
9
• Use aseptic technique (as outlined above)
• Clean the exit site at each dialysis treatment with chlorhexidine gluconate unless contraindicated. Apply antiseptic per manufacturer’s
recommendations. Allow to air dry completely.
• Cover the exit site with sterile, transparent, semipermeable dressing or per hospital protocol.
RECOMMENDED CLEANING SOLUTIONS
Catheter Luer-lock Connectors/End Caps:
• Povidone iodine (allow connectors/end caps to soak for 3 to 5
minutes)
3
WARNING:
Alcohol should not be used to lock, soak or declot polyure-
thane Dialysis Catheters because alcohol is known to degrade poly-
urethane catheters over time with repeated and prolonged exposure.
Hand cleaner solutions are not intended to be used for disinfecting
our dialysis catheter Luer-lock Connectors.
Exit Site:
• Chlorhexidine gluconate 2% solution (preferred)
3,7,8,9,10
• Chlorhexidine gluconate 4% solution
• Dilute aqueous sodium hypochlorite
• 0.55% sodium hypochlorite solution
• Povidone iodine
• Hydrogen peroxide
• Chlorhexidine patches
• Bacitracin zinc ointments in petrolatum bases
WARNING:
Acetone and PEG-containing ointments can cause failure
of this device and should not be used with polyurethane catheters.
Chlorhexidine patches or bacitracin zinc ointments (e.g.
Polysporin*
ointment) are the preferred alternative.
POST DIALYSIS
Use aseptic technique (as outlined above).
1. Flush arterial and venous lumens with a minimum of 10 mL of sterile saline.
WARNING:
To avoid damage to vessels and viscus, infusion pressures must not exceed 25 psi (172 kPa). The use of a 10 mL or larger syringe is
recommended because smaller syringes generate more pressure than larger syringes.
2. Inject heparin solution into both the arterial and venous lumens of the catheter. The appropriate heparin solution concentration and fl ushing
frequency should be based on hospital protocol. Heparin solution of 1,000 to 5,000 units/mL has been found to be eff ective for maintaining
the patency of hemodialysis and apheresis catheters. When injecting heparin solution, inject quickly and clamp extension while under posi-
tive pressure. Heparin solution volume to lock each lumen must be equal to the priming volume of each lumen. Priming volumes are marked
on each lumen.
3. Clean catheter Luer-lock connectors per hospital protocol. Attach sterile end caps to both the arterial and the venous clamping extension
pieces.
WARNING:
To prevent systemic heparinization of the patient, the heparin solution must be aspirated out of both lumens immediately prior
to using the catheter. In most instances, no further heparin solution injection is necessary for 48-72 hours, provided the catheter has not
been aspirated or fl ushed.
CATHETER REMOVAL
Evaluate the catheter routinely and promptly remove any nonessential catheter
9
per physician’s orders. After removing the catheter, apply
manual pressure to the puncture site for 10-15 minutes until no signs of bleeding are present. Then apply sterile, transparent, semipermeable
dressing or dressing per hospital protocol for a minimum of 8 hours. Follow hospital protocol regarding bedrest after catheter removal.
DISPOSAL
After use, the catheters and accessories may be a potential biohazard. Handle and dispose of in accordance with accepted medical
practice and all applicable laws and regulations.
TROUBLESHOOTING
PATIENT WITH FEVER
Patient with fever and chills following the procedure may be indicative of catheter-related sepsis. If this results, removal of the catheter may be
indicated.
INSUFFICIENT FLOW
Excessive force must not be used to fl ush an obstructed lumen. Insuffi cient blood fl ow may be caused by an occluded tip resulting from a clot
or by contacting the wall of the vein. If manipulation of the catheter or reversing arterial and venous lines does not help, then the physician may
attempt to dissolve the clot with a thrombolytic agent (e.g. TPA, Cathfl o* Activase* thrombolytic). Physician discretion advised.
CATHETER EXCHANGE
Do not routinely replace dialysis catheters to prevent catheter-related infections
9
. It may become necessary to exchange the indwelling catheter
due to a persistent rise in pressures or decrease of fl ow rates which cannot be rectifi ed through troubleshooting. Catheter exchanges should
be performed under strict aseptic conditions in which the physician should wear a cap, mask, sterile gown, sterile gloves, and use a large sterile
drape to cover the patient.
REFERENCES
1. Aitken, D.R. and Minton, J.P. “The Pinch-Off Sign: A Warning of Impending Problems with Permanent Subclavian Catheters”, American Journal
of Surgery, Vol. 148, Nov. 1984, pp.633-638.
2. Mickley, V., “Central venous catheters: many questions: few answers”, Nephrol Dial Transplant, (2002) 17:1368-1373.
3. National Kidney Foundation K/DOQI GUIDELINES 2006.
4. Sulek, CA., Blas, ML., Lobato, EB, “A randomized study of left versus right internal jugular vein cannulation in adults.” J Clin Anesth. 2000
Mar;12(2):142-5
5. Tan, P.L., Gibson, M., “Central Venous Catheters: the role of radiology”, Clin Rad. 2006, 61:13-22
6. Octavio, Bella, Colemenares, Garcia, and Flores; “Right Verses Left Internal Vein Catheterization for Hemodialysis: Complications and Impact
on Ipsilateral Access Creation”; Artifi cal Organs; 2004, 28(8):728-733.
7. The Institute for Healthcare Improvement, “How-to-Guide: Prevent Central Line Infections,” 2006.
8. The Joint Commission Hospital Accreditation Organization, National Patient Safety Goals, 2009.
9. Center for Disease Control and Prevention, “Guidelines for the Prevention of Intravascular Catheter-Related Infections,” Morbidity and Mortal-
ity Weekly Report, Aug. 9, 2002, 51(RR-10), 1-32.
10. The Society for Healthcare Epidemiology of America, “Strategies to Prevent Central Line-Associated Bloodstream Infections in Acute Care
Hospitals,” Infection Control and Hospital Epidemiology, Oct. 2008, 29(S1): S22-S30.
Other references available upon request
MR Conditional
Non-clinical testing has demonstrated the device is MR Conditional. It can be scanned safely under:
• static magnetic fi eld of 3 Tesla or less
• spatial gradient fi eld of 360 Gauss/cm or less
• maximum specifi c absorption rate (SAR) or 4 W/kg for 15 minutes of scanning.
• In non-clinical testing, the device produced a temperature rise of less than 1.4 °C at a maximum specifi c absorption rate
(SAR) of 4 W/kg for 15 minutes of MR scanning in a 3 Tesla Siemens Trio with software version B15.
For Minimal Image Artifact
• MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the extension legs.
Therefore, it may be necessary to optimize MR imaging parameters for presence of the metallic portion of the extension legs or move exten-
sion legs away from area of interest.
An issued or revision date for these instructions is included for the users information. In the event two years have elapsed between this date and
product use, the user should contact
Bard Access Systems, Inc.
to see if additional product information is available.
Revision date: March 2010.
*Bard,
Duet
and
StatLock
are trademarks and/or registered trademarks of C. R. Bard, Inc.
All other trademarks are the property of their respective owners.
© 2010
C. R. Bard, Inc.
All rights reserved.
Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 U.S.A.
1-801-522-5000
Customer Service: 800-545-0890
Clinical Information: 800-443-3385
www.bardaccess.com
DESCRIPTION
The
Duet* Long-Term Hemodialysis Catheter System
is made of
Carbothane*
radiopaque polyurethane. The catheter system is comprised of
two single 10 French lumens that allow for fl ow rates as high as 400 mL/min. Each catheter comes with an extension leg and a retention cuff for
tissue ingrowth to anchor the catheter. The arterial (red) and venous (blue) lumens are distinguished by the color coding of the printing on the
catheter and the color-coded Luer-lock connector.
STERILIZATION BY ETHYLENE OXIDE.
Sterile,
Non-Pyrogenic
Unless Package is
Damaged or Opened.
Do not use if package is damaged
MR Conditional
Non-pyrogenic
Sterilize
This product does
not contain DEHP
This product and packaging do not
contain natural rubber latex.
INDICATIONS FOR USE
The
Duet*
Long-term Hemodialysis Catheter System is indicated for use in attaining short-term or long-term vascular access for hemodialysis,
hemoperfusion, or apheresis therapy. The catheters may be inserted percutaneously into the internal jugular vein, subclavian, or external jugular
vein.
CONTRAINDICATION
This device is contraindicated for patients exhibiting severe, uncontrolled thrombocytopenia or coagulopathy.
WARNINGS
First Rib
Subclavian Vein
Clavicle
Vertebra
Internal Jugular Vein
Superior Vena Cava
Sternum
Pinch-off Area
Infraclavicular Fossa
Axillary Vein
WARNING:
If the subclavian vein is used, percutaneous insertion of the catheter
should be made into the axillary-subclavian vein at the junction of the outer and
mid-thirds of the clavicle lateral to the thoracic outlet. The catheter should not be
inserted into the subclavian vein medially because such placement can lead to com-
pression of the catheter between the fi rst rib and clavicle and can lead to damage or
fracture and embolization of the catheter.
1
Fluoroscopic or radiographic confi rmation
of catheter tip placement should be helpful in demonstrating that the catheter is not
being pinched by the fi rst rib and clavicle.
1
• Use of the subclavian vein for catheter placement may result in
subclavian vein stenosis. Subclavian vein stenosis may prevent future
use of the ipsilateral extremity for permanent access. Use of the jugular
vein is preferred.
• Alcohol or alcohol-containing antiseptics (such as chlorhexidine) may be used to
clean the catheter/skin site; however, care should be taken to avoid prolonged or excessive contact with the solutions(s).
• Acetone and PEG-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine
patches or bacitracin zinc ointments (e.g.,
Polysporin*
ointment) are the preferred alternative.
• Follow Universal Precautions when inserting and maintaining this device.
• Cardiac arrhythmias may result if the guidewire is allowed to pass into the right atrium.
• Do not tunnel through muscle.
• Clamping the catheter repeatedly in the same spot could weaken the tubing. Change the position of the extension clamps regularly to
prolong the life of the extension tubing. Avoid clamping near or on the Luer-lock connectors, as this may cause tubing fatigue and possible
disconnection. Extension tubing may develop tears or cuts if subjected to excessive pulling or contact with rough edges. Examine tubing for
damage both prior to and after each treatment.
• Catheters should be implanted carefully to avoid any sharp or acute angles which could compromise the opening of the catheter lumens.
• To prevent air embolism and/or blood loss, place thumb over the exposed orifi ce of the sheath introducer.
• To avoid damage to vessels and viscus, infusion pressures should not exceed 25 psi (172 kPa). The use of a 10 mL or larger syringe is recom-
mended because smaller syringes generate more pressure than larger syringes.
Note:
A three pound (13.3 Newton) force on the plunger of
a 3 mL syringe generates pressure in excess of 30 psi (206 kPa) whereas the same three pound (13.3 Newton) force on the plunger of a 10 mL
syringe generates less than 15 psi (103 kPa) of pressure.
• Accessories and components used in conjunction with this catheter should incorporate Luer-lock connectors.
• The heparin solution must be aspirated out of both lumens immediately prior to using the catheter to prevent systemic heparinization of the
patient.
• Failure to clamp extensions when not in use may lead to air embolism, bleeding, and possible occlusions.
• In the rare event of a leak, the catheter should be clamped immediately. Necessary remedial action must be taken prior to resuming dialysis,
hemoperfusion, or apheresis procedure.
• Do not resterilize the catheter or components by any method. The manufacturer will not be liable for any damages caused by reuse of the
catheter or accessories.
• Cannulation of the left internal jugular vein is reportedly associated with a higher incidence of complications compared to catheter place-
ment in the right internal jugular vein.
4
• Do not advance guidewire or catheter if unusual resistance is encountered.
• The blue Compression Sleeve is a necessary component of the Extension Leg Assembly. Always visually confi rm that the Compression Sleeve
remains in the Female Connector during assembly.
• Alcohol should not be used to lock, soak or declot polyurethane Dialysis Catheters because alcohol is known to degrade polyurethane
catheters over time with repeated and prolonged exposure.
• Reuse may create a risk of patient infection of user infection, compromise the structural integrity of the device, lead to device failure and/or
lead to injury, illness or death of the patient.
• The Slide Clamp, Thumb Clamp, and Plug are provided for use during catheter placement only. Do not reuse.
• Not intended for pediatric or neonatal use.
• Intended for Single Use. DO NOT REUSE. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural
integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or
death of the patient.
CAUTIONS
• Repeated over tightening of blood lines, syringes and caps will reduce Luer-lock connector life and could lead to potential connector failure.
In case of damage, clamp the catheter between the patient and the damaged area with a smooth-edged, atraumatic clamp.
• Sterile and non-pyrogenic only if packaging is not opened, damaged or broken.
• Read the instructions for use carefully before using this device.
• Federal (USA) law restricts this device to sale by or on the order of a physician.
• Care should be taken NOT to force the dilator sheath introducer into the vessel during insertion as vessel damage including perforation could
result.
• Left sided catheter placement may provide unique challenges due to the right angles formed by the innominate vein and at the left brachio-
cephalic junction with the SVC.
2,5
• Ensure that the sheath introducer is only torn externally. Catheter may need to be further pushed into the vessel as sheath introducer is torn.
• For optimal product performance, do not insert any portion of the cuff into the vein.
• Care should be taken not to advance the split sheath too far into vessel as a potential kink would create an impasse to the catheter.
• Placement and care of the
Duet*
Catheters should be performed by persons knowledgeable of the risks involved and qualifi ed in the proce-
dures.
• Do not create a sharp bend in catheter tunnel as this may cause kinking and impact fl ow.
• If the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to prevent the needle from
damaging or shearing the guidewire.
• Cutting the catheter anywhere but the pre-printed marks will result in the inability to read the catheter length and priming volumes.
• Catheter tips must be staggered by 4 cm to minimize recirculation.
• Before attempting the insertion of
Duet*
Catheters, ensure that you are familiar with the following complications and their emergency treat-
ment should any of them occur.
POSSIBLE COMPLICATIONS
These and other complications are well documented in medical literature and should be carefully considered before placing the catheter.
The use of an indwelling central venous catheter provides an important means of venous access for critically ill patients; however, the potential
exists for serious complications including the following:
• Air Embolism
• Bleeding
• Brachial Plexus Injury
• Cardiac Arrhythmia
• Catheter or Cuff Erosion through the Skin
• Catheter Embolism
• Catheter Occlusion
• Catheter Occlusion, Damage or Breakage
due to Compression between the Clavicle
and First Rib or Kinking
• Catheter-related Sepsis
• Cardiac Tamponade
• Endocarditis
• Exit Site Infection
• Exit Site Necrosis
• Extravasation
• Fibrin Sheath Formation
• Hemothorax
• Hemotoma
• Hydrothorax
• Infl ammation, Necrosis or scarring of skin
over implant area
• Intolerance Reaction to Implanted Device
• Laceration of Vessels or Viscus
• Mediastinal widening
• Perforation of Vessels or Viscus
• Pneumothorax
• Retroperitoneal Bleed
• Risks Normally Associated with Local and
General Anesthesia, Surgery, and Post-
Operative Recovery
• Thoracic Duct Injury
• Thromboembolism
• Venous Thrombosis
• Ventricular Thrombosis
• Vessel Erosion
0724304 / 1003R
