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12275964 IFU_361-19901 1/20/12 7:05 AM Page 7
RC081191-2
McGaw Park, IL
Richard Cisneroz
01-03-12
12275964
Caution: It is normal for the patient to feel some
discomfort or pain when draining fluid. If discomfort
or pain is experienced when draining, clamp the
drainage line to slow or stop the flow of fluid for a
few minutes. Pain may be an indication of infection.
Caution: Potential complications of access and
drainage of the pleural cavity include, but may not
be limited to, the following: re-expansion pulmonary
edema, pneumothorax, laceration of the lung or liver,
hypotension/circulatory collapse, wound infection,
empyema and infection in the pleural cavity.
8. If you need to change to a new vacuum bottle or
suction source for any reason, squeeze the pinch
clamp on the drainage line completely closed.
Remove the drainage line from the
vacuum/suction source and connect to a new
vacuum bottle or suction source. Release the
pinch clamp to resume draining.
9. When flow stops or the desired amount of fluid
has been removed, squeeze the pinch clamp on
the drainage line completely closed.
See Diagram (6)
10.If locked, twist the lockable access tip to unlock
it from the catheter valve. See Diagram (11)
11.Ensure the drainage line has been unlocked. With
the drainage line in one hand and the catheter
valve in the other hand, pull the lockable access
tip out of the valve in a firm, smooth motion.
See Diagram (12)
12.Clean the catheter valve with an alcohol pad. Do
not try to push anything through the valve as
damage to the valve may occur. See Diagram (13).
Warning: Do not put anything except the access tip
of the lockable drainage line or PleurX Vacuum
Bottles into the PleurX Catheter valve since this
could damage the valve. A damaged valve may allow
air into the body or let fluid leak out through the
valve when not draining.
13.Place the valve cap over the catheter valve and
twist it clockwise until it clicks into the locked
position. See Diagram (14)
14.Clean around the catheter site.
15.Place the foam catheter pad around the catheter.
16.Wind the catheter into loops and place it over the
foam pad.
17.Cover the catheter with gauze pads and secure
with a self-adhesive dressing.
18.Disconnect the drainage line from the glass
vacuum bottle or suction source. Dispose of the
used drainage line and/or used vacuum bottles in
accordance with applicable local, state, and
federal regulations. Used product may present a
potential biohazard.
Proofed by:
Dimensions checked:
Spontaneous Pleurodesis with the PleurX
Patients who drain regularly every day or every
other day may achieve pleurodesis. In a multi-center
clinical trial, drainage of the effusion at least once
every other day resulted in approximately half of the
patients achieving spontaneous pleurodesis with a
mean time to catheter removal of 29 days. ¹
Subsequent Drainage Procedures
Subsequent drainage procedures are to be
performed using the PleurX Drainage Line, PleurX
Vacuum Bottle, or the PleurX Drainage Kits. Each
drainage kit contains the necessary drainage line,
vacuum bottle, and other necessary items to
perform the drainage procedure.
It is vital that patients and/or caregivers are
carefully instructed on how to use the kit to
drain the pleural cavity. The person(s)
responsible for drainage must be able to
demonstrate they are capable of performing
the procedure.
If the patient/caregiver is not able or willing
to perform the drainage, a medical
professional should perform the drainage.
It is recommended that the patient is
periodically contacted or seen by a clinician
to evaluate treatment regimen and evaluate
catheter functional status.
Catheter Removal Procedure
It may be appropriate and/or necessary at a later
date to remove the PleurX Pleural Catheter. Three
successive attempts to drain fluid that result in less
than 50 ml of fluid removed may indicate one of the
following:
• pleurodesis has been achieved
• the catheter is loculated away from the fluid
• the catheter is occluded
1. Place the patient appropriately to access the
catheter insertion site.
2. Aseptically clean the patient's chest around the
catheter insertion site.
3. Anesthetize the site.
4. Remove any remaining sutures securing the
catheter.
5. Using forceps, dissect around the cuff to free it
from the ingrowth. Ensure that the cuff is
completely free within the tunnel.
6. Grasp the catheter in one hand and pull with a
firm, constant pressure.
7. Cover the site as appropriate.
Contains Phthalates. The benefit of treatment
outweighs the remote possibility of exposure to
phthalates.
1
Putnam JB Jr, Light RW, Rodriguez RM, et al. A
Randomized Comparison of Indwelling Pleural Catheter and
Doxycycline Pleurodesis in the Management of Malignant
Pleural Effusions. Cancer 1999; 86; 1992-1999.
4
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