Adverse Events - Codman AS 10 Manual Del Usuario

Adverse Events

Adverse Events
Adverse events related to emptying, filling, or refilling the drug reservoir include:
• Contamination of the drug reservoir resulting in infection, such as meningitis;
• Injection errors, which can lead to tissue damage or a drug under- or overdose; or
• Overfilling of the drug reservoir, which can lead to drug overdose or damage
to the pump.
Complications relating to the drug therapy, such as:
• drug toxicity (local and systemic) and its related side effects;
• complications due to the use of a drug that is not approved for intrathecal
administration;
• complications due to the use of drugs that are not approved for use with the system;
• complications due to use of an approved drug or diluent that is out of specification;
• extravasation.
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