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CareFusion PleurX 50-9050 Mode D'emploi page 5

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PleurX Peritoneal Catheter Procedure
Product Information
The PleurX Peritoneal Catheter consists of a
fenestrated silicone catheter with a valve mechanism
and a polyester cuff. A barium sulfate stripe runs the
entire length of the catheter. (Figure 1) The valve is
designed to prevent the passage of air or fluid in
either direction unless it is accessed with the
specifically matched drainage line, access kit, or
vacuum bottles provided by CareFusion. The PleurX
Peritoneal Catheter is designed exclusively for use
with the PleurX Vacuum Bottles, glass vacuum
bottles, and the PleurX Lockable Drainage Line for
connection to wall suction or portable suction.
PleurX Peritoneal Catheter
Polyester
Cuff
Fenestrations
25.5 cm
15.0 cm
Internal Portion
Catheter: 71.0 cm
(1)
PleurX Lockable Drainage Line
Lockable Access Tip
Drainage Line: 61 cm
(2)
Indications for Use
The PleurX Peritoneal Catheter Mini Kit System is
indicated for intermittent, long term drainage of
symptomatic, recurrent, malignant ascites that does
not respond to medical management of the underlying
disease and for the palliation of symptoms related to
recurrent malignant ascites. The PleurX Peritoneal
Catheter is indicated for adults only.
The PleurX Lockable Drainage Line (Figure 2) is used
to drain fluid using standard wall suction, water seal
drainage system, vacuum bottle or other appropriate
method.
Contraindications
Use of the PleurX Peritoneal Catheter System is
contraindicated in the following situations:
1. When the peritoneal cavity is multi-loculated, and
the drainage of a single loculation would not be
expected to provide relief of dyspnea or other
symptoms.
2. When there is a coagulopathy.
3. When the peritoneal cavity is infected.
4. When the patient is known or suspected to be
allergic to materials contained in the device.
DCN 60578-2
Vernon Hills, IL
Proofed by:
Richard Cisneroz
Dimensions checked:
05-30-17
361-35001
Warnings
Do not put anything except the access tip of the
PleurX Lockable Drainage Line, PleurX Catheter
Access Kit, or PleurX Vacuum Bottles into the PleurX
Catheter valve since any other device could damage
the valve. A damaged valve may allow air into the
body or let fluid leak out through the valve when not
draining.
Cautions
For single use only. Re-use may result in a non-
functional product or contribute to cross
contamination.
Sterile technique should be used when placing and
draining the catheter.
Care must be taken when inserting the guidewire
introducer needle to avoid puncturing or lacerating
Valve
the liver or bowel.
If the needle is left in place with the guidewire
introducer, damage to the guidewire may result if
30.5 cm
withdrawn through the needle.
External Portion
The fenestrations must be entirely within the
peritoneal space to avoid leakage into the tunnel
tract. Take patient size, tunnel length and the catheter
length into account when placing the catheter.
Potential complications of access and drainage of the
Roller Clamp
peritoneal cavity include, but may not be limited to,
the following: laceration of liver or bowel,
hypotension/circulatory collapse, electrolyte
imbalance, protein depletion, ascites leakage,
Luer Lock
peritonitis, wound infection, tumor growth in the
catheter tunnel, and loculation of the peritoneal
cavity.
Removal of chylous malignant ascites could
exacerbate protein depletion or related nutritional
complications.
Sterility
This product has been sterilized. It is for single use
only and is not to be resterilized. Do not use if
package is damaged. CareFusion will not be
responsible for any product that is resterilized, nor
accept for credit or exchange, any product that has
been opened but not used.
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