Idiomas disponibles
Idiomas disponibles
•
Ensure proper needle placement (held perpendicular to the pump and inserted
completely to the needle stop) before filling the reservoir.
•
Do not use excessive force when inserting the needle into the central port;
this can damage the needle tip. Do not use a filling needle if the tip is bent.
Using a bent needle will cause damage to the central port, and may result in
a failure to administer solution appropriately or cause leakage of drug solution
into the pump pocket.
Bolus Port Precautions
•
Use only the MedStream Bolus Kit for all bolus port procedures. The bolus
needle is designed specifically for use with this pump. Use of other
needles can damage the bolus port or result in a failure to administer
solution appropriately.
•
Use fluoroscopy, if needed, to locate the bolus port postoperatively.
•
Do not use excessive force when inserting the needle into the bolus port; this
can damage the needle tip. Do not use a bolus needle if the tip is bent. Using
a bent needle will cause damage to the bolus port, and may result in a failure
to administer solution appropriately.
•
Do not overpressurize the bolus port when injecting fluids. Small syringes
can generate very high fluid pressure. Do not use syringes smaller than 10 mL
for bolus port injections.
Adverse Events
Potential adverse events associated with the use of infusion pumps include, but
are not limited to the following.
The development of an inflammatory mass at the tip of the implanted intraspinal
catheter, which may be evidenced by:
•
a progressive change in the character, quality, or intensity of pain
•
an increase in the level of pain and degree of pain despite dose escalation
•
sensory changes (i.e. numbness, tingling, burning)
•
hyperesthesia and/or hyperalgesia
If the presence of an inflammatory mass is suspected, perform a full evaluation.
Presentations that require immediate diagnosis include bowel and/or bladder
dysfunction, myelopathy, Conus Syndrome, gait disturbances or difficulty
ambulating, and paraparesis or paralysis.
Failure of the pump, resulting in the cessation of drug therapy, which may cause:
•
a return of underlying symptoms
•
drug withdrawal symptoms or
•
the need for surgical removal of the pump
A change in the flow rate, due to pump failure or due to exposure to temperature
or pressure extremes, with underinfusion or overinfusion of the drug, which
may cause:
•
a return of underlying symptoms
•
drug withdrawal symptoms
•
drug overdose
•
the need for surgical removal of the pump
Catheter performance problems, such as kinking, disconnection, leakage,
breakage, occlusion (complete or partial), dislodgment, migration, formation of
fibrosis or hygroma, which may cause:
•
delivery of the drug to an inappropriate site, such as the pump pocket or
subcutaneous tissue
•
drug withdrawal symptoms
•
a return of underlying symptoms
•
free-floating catheter in the cerebrospinal fluid (CSF)
•
underinfusion of the drug
•
CSF leakage resulting in headache, subcutaneous collection of CSF,
or problems related to central nervous system (CNS) pressure
•
damage to the spinal cord
•
hemorrhage
•
the need for surgical replacement of the catheter
•
organ failure
•
stroke
•
death
Complications relating to the drug therapy, such as:
•
drug toxicity (local and systemic) and its related side effects
•
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
Adverse events arising from the surgical procedure, such as:
•
Pump implanted upside down
•
Seroma, hematoma, erosion or infection of the pocket
•
CSF leakage leading to headache, subcutaneous collection of CSF, or
problems related to CNS pressure
•
Radiculitis, arachnoiditis, or meningitis
•
Damage to the spinal cord
•
Headache
•
Anesthesia complications
•
Other surgical complications, such as bleeding, infection, and fever
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