Possible Complications - MedComp DIGNITY Instructions D'utilisation

Chambre d'injection implantable en plastique à injecteur automatique
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  • FRANÇAIS, page 27
I. Prior to Placement:
Examine package carefully before opening to confirm its integrity
and that the expiration date has not passed. The device is supplied
in a sterile package and is non-pyrogenic. Do not use if package is
damaged, opened or the expiration date has passed. STERILIZED
BY ETHYLENE OXIDE.
Do not resterilize or reuse. Re-use may lead to infection or
illness/injury.
Inspect kit for presence of all components.
Check patient's records, and ask patient, whether they have any
known allergies to chemicals or materials that will be used during
the placement procedure.
Fill (prime) the device with sterile heparinized saline or normal
saline solution to help avoid air embolism. Remember that some
patients may be hypersensitive to heparin or suffer from heparin
induced thrombocytopenia (HIT) and these patients must not have
their port primed with heparinized saline.
When using an introducer kit, verify that the catheter fits easily
through the introducer sheath.
II. During Placement:
Do not allow accidental device contact with sharp instruments.
Mechanical damage may occur. Use only smooth edged, atraumatic
clamps or forceps.
Take care not to perforate, tear, or fracture the catheter during
placement. After assembling catheter to port, check assembly for
leaks or damage.
Do not use the catheter if there is any evidence of mechanical
damage or leaking.
Do not bend catheter at sharp angles during implantation. This can
compromise catheter patency.
Carefully follow the connection technique given in these
instructions to ensure proper catheter connection and to avoid
catheter damage.
Do not use sutures to secure catheter to the port stem as it could
collapse or damage the catheter.
When using peel-apart introducers:
– Carefully insert the introducer and catheter to avoid inadvertent
penetration to vital structures in the thorax.
– Avoid blood vessel damage by maintaining a catheter or dilator as
internal support when using a peel-apart introducer.
– Avoid sheath damage by simultaneously advancing the sheath
and dilator as a single unit using a rotational motion.
POSSIBLE COMPLICATIONS:
The use of a subcutaneous port 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 Port Erosion Through the Skin
Catheter Embolism
Catheter Occlusion
Catheter Occlusion, Damage or Breakage Due to Compression
Between the Clavicle and First Rib
Catheter or Port Related Sepsis
Device Rotation or Extrusion
Endocarditis
Extravasation
Fibrin Sheath Formation
Hematoma
Hemothorax
Hydrothorax
Intolerance Reaction to Implanted Device
Inflammation, Necrosis, or Scarring of Skin Over Implant Area
Laceration of Vessels or Viscus
Perforation of Vessels or Viscus
Pneumothorax
Spontaneous Catheter Tip Malposition or Retraction
Thoracic Duct Injury
Thromboembolism
Vascular Thrombosis
Vessel Erosion
Risks Normally Associated with Local or General Anesthesia,
Surgery, and Post-Operative Recovery
These and other complications are well documented in medical
literature and should be carefully considered before placing the
port.
STERILE EO
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