Appendix A-Refilling The Pump; Contraindications; Preliminary Procedures - Medtronic SYNCHROMED II Manuel D'implantation

Filename Date Time
UC200xxxxxx EN
4.6 x 6.0 inches (140 mm x 197 mm)
Appendix A—Refilling the pump

Contraindications

Medtronic refill kits are contraindicated for all catheter access port procedures.
w
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.
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 spill or leak vesicant or cytotoxic drug into adjacent tissue during pump
procedures. Spillage or leakage of vesicant drug into adjacent tissue can result in
significant local tissue damage.

Preliminary procedures

1. Gather the following sterile equipment:
From the appropriate refill kit:
▪
Extension tubing set with clamp
▪
0.22-µm (micron) filter
▪
22-gauge noncoring needle
22 English 8637 2009-10
2009-10
Medtronic Confidential
ImplantManual.xsl - IPGTemplate.fm
Template version: 03-03-2010
M221311A028 Rev A