Indications; Contraindications; Warnings; Precautions - Flowonix Prometra Manual Del Usuario

Indications

The Refill Kit is indicated for use in patients with a Prometra Programmable Infusion System. It is
intended for use in refilling the Drug Reservoir of the Pump.

Contraindications

The Refill Kit is contraindicated when the presence of infection, bacteremia or septicemia is known or
suspected.

Warnings

• The Refill Kit is supplied sterile and non-pyrogenic. The package should be examined carefully prior to
opening. Do not use the contents if there is any evidence of damage to the package or package seal that
could compromise sterility. Do not resterilize contents of any damaged or opened packages.
• After use, this product is a potential biohazard. Handle and discard in accordance with accepted
medical practice and all applicable laws and regulations.
• Pain on injection that was not noted during previous injections may be an early sign of infection.
• Use of this device should only be conducted by qualified medical personnel specifically trained in its
use. Use of this device by non-qualified or untrained personnel could lead to serious consequences
involving under- or over-medication. In the event of over-medication, refer to the approved drug labeling
for appropriate treatment.
• Prior to infusion of any substance into the pump, medical personnel should be familiar with and
observe all warnings, cautions, contraindications, and instructions as specified by the manufacturer of
the infusate.

Precautions

• Read and follow all instructions.
• Do not inject contrast media into the drug refill/reservoir septum as this may impair or damage the
pump operation.
• Examine the package carefully before opening to confirm its integrity and that the expiration date has
not passed.
• If therapy is discontinued for an extended period, the pump should be emptied of the drug and filled
with a preservative-free sterile saline solution to maintain catheter patency.

Adverse Events

The use of implanted pumps provides an important means of treating patients with intractable pain.
However, the potential exists for serious complications. Please refer to the appropriate Prometra
Programmable Pump instructions for a complete list.

Equipment

• Prometra Refill Kit
• Prometra Programmer (not sterile)
The following items may be needed and are not provided:
• Sterile programmer sleeve
• Refill syringe, 20 mL
• Drug solution (infusate) for refill, not to exceed 20 mL
• Sterile preservative-free 0.9% saline
• Sterile pen
• Medical grade printer (not sterile)
• Programmer printer cable (not sterile)
Page 2 REFILL KIT, For use with Prometra Programmable Infusion Systems
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