PROMETRA® II PROGRAMMABLE PUMP
Page 12 of 38
SPECIFIC POST-MRI INSTRUCTIONS
Protocol for Prometra
®
(REF 11827) and Prometra
®
II (REF 13827) Programmable Pumps
Post-MRI Procedure
1.
Confirm Pump Operational Status –
a.
Inquire the pump with the programmer to verify pump operation and settings.
b.
Confirm that settings are unchanged from the Pre-MRI settings, e.g., flow rate must be 0.0
mg/day.
c.
If the programmer displays any pump errors, proceed to Step 2 “Clear Pump Errors”.
d.
If no pump errors are displayed, proceed to Step 3 “Inlet and Outlet Valve Closure
Confirmation”.
2.
Clear Pump Errors
a.
If pump errors are displayed from the Inquiry performed in Step 1, perform an Emergency Pump
Stop using the programmer, and contact Flowonix Technical Solutions for assistance 855-356-9665.
b.
If pump errors are cleared, proceed to Step 3.
3.
Confirm Inlet / Outlet Valve Closure
a.
Attempt to aspirate the Drug Reservoir through the Refill Port. To aspirate, attach the 22G
non-coring needle (available in Refill Kit) to a sterile syringe.
b.
Advance needle through center Refill Port Septum until needle tip resides completely inside
the Drug Reservoir.
c.
Pull a vacuum with the syringe for approximately 10 to 30 seconds to confirm Inlet / Outlet Valve
closure.
Warning: If any significant volume (>1ml) is retrieved, it may be indicative that the pump Inlet /
Outlet Valves are open, providing direct access to the catheter/cerebral spinal fluid; If so, DO NOT
proceed with the refill since the pump may not be operating properly. The pump may need to be
explanted and replaced. For questions, Contact Flowonix Technical Solutions for assistance at:
855-356-9665.
4.
Refill The Drug Reservoir
a.
Proceed to refill the Drug Reservoir in accordance with the refill procedure defined in the
Refill Kit Instructions for Use.
b.
Confirm the correct prescription is programmed, or program a new prescription.
Warning: A period of observation should follow the Refill Procedure to closely monitor patients for
clinical symptoms of underdose or overdose based upon Infumorph’s prescribing information.
WARNING: IF PUMP STATUS CANNOT BE PROPERLY CONFIRMED, DO NOT
PROCEED SINCE
THE PUMP MAY NOT BE OPERATING PROPERLY, PLEASE CONTACT FLOWONIX TECHNICAL
SOLUTIONS FOR ASSISTANCE AT: 855-356-9665.
