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•
If the pump alarm sounds, immediately investigate. Immediately empty
the pump reservoir if the error message is "Pump Hardware Failure (X).".
This condition can cause a drug overdose.
Pump Filling Warnings
•
Air in the pump reservoir may cause the infusion rate to exceed the
programmed rate, leading to drug overdose. Care should be taken to remove
all air from the drug syringes and the filling assembly prior to filling the pump
reservoir. Ensure that all filling components are primed with fluid and visually
verify that there are no air bubbles in the filling assembly prior to filling the
pump reservoir.
•
Do not overfill the reservoir. Identify the reservoir capacity before filling
the pump. Empty the drug reservoir completely before refilling the pump.
Overfilling can result in overinfusion, which can lead to drug overdose or
cause damage to the pump.
•
Use only the needle provided in the MedStream Refill Kit for refilling the
drug reservoir. This needle is designed specifically for use with this pump. Use
of other needles can damage the central port or result in a failure to administer
solution appropriately.
Bolus Port Warnings
•
Perform the following steps to prevent errors during manual delivery of
a bolus dose by injection. Because a significant amount of drug can be
present in the bolus port, pump catheter, and intraspinal catheter, failure
to follow these steps can result in drug overdose.
Identify the location of the central port and the bolus port
Use the bolus needle provided in the MedStream Bolus Kit for accessing
the bolus port
Aspirate fluid from the bolus port to ensure drug removal. Refer to the
catheter length conversion information in Technical Specifications
Drug Warnings
•
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 MedStream
pump. Using incompatible or contaminated (out of specification) drug
solutions can damage the pump flow restrictor chip and cause an increase
or decrease in flow rate. This can lead to serious complications, including
overdose, return of underlying symptoms, and death.
•
Based on studies carried out by Codman that evaluated precipitation of
Morphine Sulfate for Intrathecal Injection at varying pH levels, the use of
preservative-free morphine sulfate solutions with pH levels above 6.5 is not
recommended for these pumps. In particular, we have found that higher
concentrations of morphine sulfate solutions (>10 mg/mL) might be more
susceptible to precipitation when the pH levels of the drug are at or near the
upper pH limits specified in USP requirements for this drug (i.e., at or near
pH 6.5). Assess the 0.9% preservative-free sodium chloride injection diluent
for pH levels to assure that it will not adversely elevate the pH of the final drug
solution to be placed into the pumps. Observe the mixtures for any evidence
of precipitation formation prior to introducing them into the pumps. The above
is particularly important when higher concentrations of morphine sulfate are
being used in the pump.
Precipitation of morphine could result in an accumulation of the precipitates
in the flow path causing possible slowing or stoppage of flow through the
flow-restrictor chip. This can lead to inadequate pain relief and/or the need to
remove and replace the pump.
•
Do not inject into the pump catheter or the intraspinal catheter; a drug
overdose might result.
•
Consider the drug concentration, dose and rate relationships before selecting
the pump volume and programming the flow rate. Failure to consider these
factors can lead to under- or overdose.
Catheter Warnings
Record the original catheter length and inner diameter, the length implanted, and
the length cut off for each catheter used. The control unit requires this information
for calculating the bridge bolus amount. There is no substitute for this information.
Note: For Codman catheters 70020, 60-2914, and 60-2918, only the discarded
length is needed. The Control Unit is pre-programmed with all other information for
these catheters.
Magnetic Resonance Imaging (MRI) Safety Information
MedStream Programmable Infusion Pumps (REF 91-4200 and 91-4201) are
"MR Conditional" in accordance with the American Society for Testing and
Materials (ASTM) Standard F2503-05.
Non-clinical testing has demonstrated that the exposure of a MedStream
Programmable Infusion Pump to an MRI procedure may cause a reset event
that will stop the infusion and elicit an audible alarm or beeping. This reset event
does NOT cause loss of memory data. Upon termination of the MRI procedure,
interrogate the MedStream Programmable Infusion Pump with the MedStream
Control Unit to obtain the pump's current status. If the infusion program has
stopped, restart the program using the MedStream Control Unit.
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