Instructions for Use – Refilling the Implanted Pump
B. Emptying the Drug Reservoir of the Remaining Drug (see Figure 3)
CAUTION: Always ensure that the stopcock handle is positioned
correctly, as outlined in the procedure that follows. Positioning the
stopcock handle incorrectly can result in an unintended effect, such
as drug solution refluxing from the pump into the 60-mL syringe.
Refluxed fluid from the pump is of particular concern in the
following instances:
•
When changing the drug – because the new drug could become
altered with refluxed drug
•
When changing the concentration of the drug – because the new
drug concentration could become altered when refluxed drug
solution is mixed with the new
If either of these instances occurs, discard the refill kit and drug
solution in the appropriate manner. Use a new refill kit and new
quantity of drug solution.
Perform the following calculation to determine the volume of drug
solution removed from the pump, if the pump contents reflux into
the 60-mL syringe:
Volume (mL) of drug solution in the 60-mL syringe
+ Volume (mL) of drug solution in the 10-mL syringe
+ 3 mL (amount of drug solution used to prime the system)
– Original amount (mL) of new drug solution
= Amount of drug solution refluxed from the pump (mL)*
*Use this amount in Step 2e and Step 3a, which follow.
1.
Set up
a.
Palpate the pump. Locate both the central port and the bolus port.
b.
Disinfect a wide area of skin over and around the central port; cover the
prepared area with the sterile fenestrated drape.
2.
Empty the drug reservoir
a.
Connect the collection syringe onto the stopcock. Firmly place the silicone
stopper onto the end of the collection syringe barrel.
b.
Ensure that the stopcock handle points to the filling needle. Remove the
protective cover from the filling needle. Holding the filling needle perpendicular
to the pump, puncture the central port. Insert the filling needle until it contacts
the needle stop. CAUTION: If the needle does not contact the needle stop,
it will not be possible to remove drug from the pump.
Instructions for Use – 14
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c.
Loosen the silicone stopper and hold the collection syringe upright. Turn the
stopcock handle so it points to the perpendicular fitting. The contents of the
reservoir will reflux into the collection syringe. If reflux does not appear,
check the position of the filling needle. If needed, twist the needle to ensure
that it penetrates the central port. If, after checking the filling position,
no reflux is present, consult Appendix C: Troubleshooting.
d.
When the reflux of drug has stopped, wait an additional 30 seconds to
ensure that the pump is empty. Turn the stopcock handle so it points
to the filling needle.
e.
Record the volume removed from the drug reservoir.
f.
Secure the silicone stopper firmly to prevent spillage. Turn the collection syringe
upside down before disconnecting it from the connecting tube to prevent small
amounts of spillage.
g.
Remove the collection syringe from the stopcock. The filling needle remains
in place in the central port; the tubing and remainder of the refill assembly
are attached to the needle.
3.
Calculate the flow rate
a.
Calculate the flow rate according to the following equation:
Refilling volume from – Volume removed from
previous visit (mL)
current visit (mL)
Running time since last refill (days) [24 h]
If the difference between the calculated flow rate and the set flow rate is
unacceptable, refer to Appendix C: Troubleshooting.
b.
Dispose of the syringe and refluxed solution appropriately.
c.
If there will be a change in the drug solution (either the drug itself or the
concentration), proceed to Rinsing the Drug Reservoir. If there will be no change
to either the drug or the concentration, proceed to Refilling the Drug Reservoir.
= Calculated flow rate
(mL/24 h)
9/27/2011 12:26:23 PM
9/27/2011 12:26:23 PM