Adverse Events; Product Description - Codman MedStream Gebrauchsanweisung

Use only the needle provided with the MedStream Bolus Kit for accessing the
bolus port of a MedStream pump. This needle is designed specifically for use with
the pump. The use of other needles can damage the bolus port and/or result in
a failure to administer solution appropriately.
If local or systemic infection is suspected, use extreme caution injecting a bolus.
If infection is suspected, perform appropriate diagnostic procedures
and intervention.
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.
Use only preservative-free solutions for intrathecal applications.

Adverse Events

Adverse events related to bolus injections include:
• Contamination of the bolus channel resulting in infection, such as meningitis
• Injection errors, which can lead to tissue damage or a drug under-
or overdose
Complications relating to the drug therapy may arise, such as:
• drug toxicity (local and systemic) and its related side effects
• complications due to the use of a drug that is not approved for
intrathecal administration
• 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

Product Description

The MedStream Bolus Kit (Figure 1) contains a needle designed for use only with
the MedStream infusion pump. The tip of the needle is closed; the drug solution
exits the needle through an opening along the shaft of the needle. See Figure 2.
The Bolus Kit contains the following components, provided sterile:
• Two bolus needles with purple luer-lock
• Two 10 mL syringes
• Connecting tube with stopcock
• Fenestrated drape
• Filter, 0.2 micron
4
CODFR11052zz03svn.indb 4 CODFR11052zz03svn.indb 4
1
10 mL syringes (2)
Filter
Stopcock
(open)
Bolus needles (2)
2
Opening for bolus injection
Closed tip 22-gauge needle
Connecting tube
Luer lock
connector
6/29/2011 2:28:40 PM 6/29/2011 2:28:40 PM