Indications For Use

Hickman Hemodialysis/Apheresis Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. They are available in single lumen (10.8 and 14.4 Fr), and a dual lumen (13.5 Fr.), catheter configurations in various lengths.

All Hickman* Hemodialysis/Apheresis central venous catheters are designed for hemodialysis, apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman* dual lumen hemodialysis / apheresis catheter incorporates two large,equal size lumens appropriate for hemodialysis and apheresis procedures.

Contraindications

This device is contraindicated whenever:

• The presence of device related infection, bacteremia, or septicemia is known or suspected.

• The patient’s body size is insufficient to accommodate the size of the implanted device.

• The patient is known or is suspected to be allergic to materials contained in the device.

• Severe chronic obstructive lung disease exists (percutaneous subclavian placement only.)

• Past irradiation of prospective insertion site.

• Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.

• Local tissue factors will prevent proper device stabilization and/or access.

Warnings

• Intended for Single Patient Use. DO NOT REUSE. These products are single use devices and should never be reimplanted. Reuse carries with it the attendant concern of cross-infection regardless of the cleaning or sterilization method. Resterilization of incompletely cleaned devices may not be effective. Any device that has been contaminated by blood should not be reused or resterilized.

• After use, this product may be a potential biohazard. Handle and dispose in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

• Pinch-off Prevention: Catheters placed percutaneously or through a cut-down, into the subclavian vein, should be inserted at the junction of the outer and middle 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 compression of the catheter between the first rib and the clavicle, which can cause damage and even severance of the catheter. A radiographic confirmation of catheter placement should be made to ensure that the catheter is not being pinched by the first rib and clavicle.

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 • Cardiac Tamponade • Catheter or Cuff Erosion Through Skin • Catheter Embolism • Catheter or Cuff Occlusion • Catheter Occlusion, Damage or Breakage due to Compression Between the Clavicle and First Rib • Catheter-related Sepsis • Endocarditis • Exit Site Infection • Exit Site Necrosis • Extravasation • Fibrin Sheath Formation • Hematoma • Hemothorax • Hydrothorax • Intolerance Reaction to Implanted Device • Laceration of Vessels or Viscus • Perforation of Vessels or Viscus • Pneumothorax • Spontaneous Catheter Tip Malposition or Retraction • Thoracic Duct Injury • Thromboembolism • Venous Thrombosis • Ventricular Thrombosis • Vessel Erosion • Risks Normally Associated with Local and General Anesthesia, Surgery, and Post-Operative Recovery