Warnings - Codman AS 10 Manual Del Usuario

Warnings

WARNINGS
Improper use of implanted infusion pumps can result in drug under- or overdose. Users
must comply with product instructions for initial filling and refilling of the pump. Only
qualified medical personnel must perform these procedures.
Do not mix drugs. The effects of mixing drugs in the pump are not known.
Use only the drugs and diluent listed in Indications with the ARCHIMEDES pump.
Using incompatible or contaminated (out of specification) drug solutions can damage
the pump flow restrictor chip and cause an increase in flow rate. This can lead to serious
complications, including overdose and death.
The physician must consider the drug concentration, dose, and flow rate relationships of the
pump before selecting the pump volume and flow rate. Failure to consider these factors can
lead to a drug under- or overdose.
Do not overfill the drug reservoir. Always identify the drug reservoir capacity (volume)
before performing a filling procedure. Always follow the instructions for removing
the remaining drug solution before refilling the drug reservoir. Failure to remove the
remaining drug solution can result in overfilling the drug reservoir. Overfilling can result
in overinfusion, which can lead to a drug overdose or cause damage to the pump.
It is very important to correctly calculate the infusion solution. Calculation errors can result in
overinfusion or underinfusion. Refer to Appendix B: Calculating the Drug Infusion Solution.
It is very important to access the central port during refill procedures. An error in
accessing the central port can result in tissue damage or a drug under- or overdose, or drug
withdrawal symptoms.
Never inject into the pump catheter or the intraspinal catheter; a drug under- or overdose
or damage to the catheter can result.
Do not use the needle provided with the refill kit for accessing the bolus port.
Injection in the bolus port or into the pump pocket can result in drug overdose. To prevent
injection errors:
• identify the location of the central port and the bolus port;
• use the SURECAN Filling Needle provided in the CODMAN Refill Kit (AS 10) for
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accessing the central port;
• confirm drug reflux into the syringe barrel during the filling procedure.
After rinsing the drug reservoir, intrathecal delivery of the new drug solution from the
drug reservoir will be delayed until the solution traverses the total catheter length. Carefully
calculate the amount of the delay, based on the total catheter length and the flow rate,
before administering additional medication by another delivery method.
Warnings – 6
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