Appendix B-Accessing The Catheter Access Port; Contraindications - Medtronic SYNCHROMED II Manuel D'implantation

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4.6 x 6.0 inches (140 mm x 197 mm)
Appendix B—Accessing the catheter access port

Contraindications

Medtronic catheter access port kits are contraindicated for all refill procedures.
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Be certain you are accessing the correct port when injecting fluids into the reservoir fill
port or accessing the catheter access port of an implanted pump. ALWAYS:
identify the pump model and reservoir volume.
identify the location of the reservoir fill port and the catheter access port.
use the instructions, noncoring needles, and other accessories provided in the
appropriate kit.
verify the location of the correct port during needle insertion, using other medical
procedures as appropriate.
refer to the appropriate drug labeling for indications, contraindications, warnings,
precautions, adverse events, and dosage and administration information.
Improper injection into the pump pocket or catheter access port allowing drug leakage
into surrounding tissue can result in significant tissue damage or a loss of or change in
symptom control, drug withdrawal symptoms, or a clinically significant or fatal drug
underdose. Improper injection into the catheter access port can result in a clinically
significant or fatal drug overdose. Observe the patient after the pump refill procedure for
any signs or symptoms that could indicate a pocket fill or any other drug-related adverse
event due to the refill procedure.
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Cautions:
Use strict aseptic technique when accessing the reservoir fill port or the catheter
access port. Failure to use aseptic technique can contaminate fluids or tissues and
result in local or systemic infection.
Use extreme caution when accessing the reservoir fill port or catheter access port
of the implanted pump if local or systemic infection is suspected. Avoid contaminating
the system or further spreading the infection. Local or systemic infection may require
surgical revision or replacement of infusion system components.
Do not use excessive force, do not use syringes smaller than 10 mL, and do not
exceed an injection rate of more than 5 mL per minute when accessing the catheter
access port. Failure to follow these instructions can create excessive pressure and
cause catheter damage or disconnection allowing leakage into surrounding tissue
resulting in tissue damage or a loss of or change in therapy, which may lead to a
return of underlying symptoms, drug withdrawal symptoms, or a clinically significant
or fatal drug underdose. In addition, do not rock the needle sideways while injecting.
Rocking can break the needle inside the pump, requiring surgical revision or
replacement.
Always use a bacterial-retentive filter when injecting through the catheter access
port. The catheter access port does not contain a filter. Injecting into the catheter
28 English
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