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What are the risks of the PleurX™ Pleural Catheter System?
Potential complications from this procedure include:
1. Collapsed lung (pneumothorax)
2. Fluid in the lungs (re-expansion pulmonary edema)
3. Low blood pressure (hypotension)
4. Failure of the heart and blood vessels (circulatory collapse)
5. Infection
6. Injury to the lung
What are the warnings and precautions of the PleurX™ Pleural
Catheter System?
A complete list of warnings and precautions for catheter placement is in the
PleurX™ Pleural Catheter's 'Instructions for Use,' which is located at eifu.
bd.com.
• The catheter and bottle are meant to be used together. Do not connect the
catheter or bottle to anything else. It could cause damage to the catheter
valve.
• Your doctor may not be able to place the catheter if you have severe skin
problems where the catheter would be placed, such as tumor invasion or
psoriasis.
A complete list of warnings and precautions for the drainage procedure is in
the PleurX™ Drainage Procedure 'Instructions for Use,' which is located at
eifu.bd.com.
Fluid Drainage:
• Before draining fluid from your chest, it is very important that the person(s)
draining the fluid is properly trained. If you feel uncomfortable by yourself,
a caretaker, nurse, or doctor should drain the fluid from your chest.
• Keep the valve on your PleurX™ Catheter and the access tip on the
drainage line clean. Keep them away from other objects to help avoid
contamination.
• Make sure that the valve and the access tip are securely connected when
draining. If they separate, clean the valve with an alcohol pad and use a
new drainage line to avoid potential contamination.
• It is normal to feel some pain when draining fluid. If you feel pain when
you drain, roll the wheel on the roller clamp towards the bottle to slow or
stop the flow of fluid for a few minutes.
• To help avoid skin irritation, make sure the exit site and skin around the
catheter are dry before following the steps for the dressing procedure.
How often and how much fluid should I drain from my chest?
You should drain fluid as directed by your doctor, usually every 1–2 days.
Do not drain more than 1,000 mL of fluid from your chest at one time. If you
drain 1,000 mL of fluid, stop drainage, and notify your doctor if you still have
shortness of breath. Ask your doctor before changing how often you drain
fluid.
When should I NOT drain fluid from my chest?
It is normal to feel some pain or discomfort when draining fluid. If you feel
pain when you or your caretaker drain, roll the wheel on the roller clamp
toward the bottle to slow or stop the flow for a few minutes. If you don't feel
better after doing this, or the pain is bad, contact your doctor or nurse. Pain
may be an indication of infection or other problems.
Signs of infection are pain, redness (erythema), warmth to touch, swelling
(edema), fever, or fluid around the catheter site. If you or your caretaker see
signs of infection, finish the drainage procedure, and consult your doctor or
nurse.
When should I contact my doctor?
You should contact your doctor if:
1. You think your catheter is infected (signs of infection are pain, redness
(erythema), warmth to touch, swelling (edema), fever, and fluid around the
catheter site).
2. You have trouble breathing, low blood pressure, or other concerning
symptoms.
3. Your shortness of breath is not relieved after draining 1,000 mL from your
chest.
4. Less than 50 mL of fluid drained in 3 drainage procedures in a row.
5. The appearance (color, thickness, etc.) of the fluid changes significantly
between drainages.
6. You continue to experience symptoms, but little or no fluid drains from the
catheter.
Can my PleurX™ Pleural Catheter be used with suction devices other
than the PleurX™ Drainage Bottle?
Yes, the PleurX™ Pleural Catheter can be used with additional suction
devices such as wall suction, glass vacuum bottles or other portable suction
devices. Your caretaker, nurse, or doctor will decide what suction device is
appropriate to drain your fluid. For more information on alternative suction
devices, please consult the PleurX™ Pleural Catheter's 'Instructions for
Use,' which is located at eIFU.bd.com
Can the PleurX™ Pleural Catheter be removed?
Yes. Your doctor may remove the catheter if he or she determines you
no longer need it. You may have a PleurX™ Pleural Catheter as long as
needed or until fluid build-up stops. If you need the catheter for a long time,
it may need to be replaced with a new catheter.
What is the lifetime of the PleurX™ Pleural Catheter?
You may have the PleurX™ Pleural Catheter as long as needed or until
fluid build-up stops. If the catheter breaks or becomes clogged, it may need
to be replaced with a new catheter. Your doctor will determine if a catheter
replacement might be needed.
Do I have to follow-up with my healthcare provider?
Yes. It is important to follow your doctor's instructions and to keep all follow-
up appointments. Your doctor will monitor your status and check that your
catheter is working properly.
What do I do with the implant card?
Keep your patient implant card with you. Your patient implant card has
important information about your PleurX™ Pleural Catheter. Be sure to show
your implant card to any doctors that you see.
Can I have Magnetic Resonance Imaging (MRI) with the PleurX™
Pleural Catheter?
Yes, the catheter will not cause problems during an MRI. If you need an
MRI, tell your doctor or MRI technician that you have a PleurX™ Pleural
Catheter. Show them your implant card. Your doctor can access MRI
information for the PleurX™ Pleural Catheter in the instruction for use (IFU),
which is located at eifu.bd.com.
Non-clinical testing has demonstrated that the PleurX™ Catheter is MR
safe. In non-clinical testing, the image artifact caused by the device extends
approximately 2 mm from the device when imaged with a gradient echo
pulse sequence and a 3.0 T MRI system.
For Australia: Any serious incident that occurs in relation to the device
should be reported to Becton Dickinson (BD) and the Therapeutic Goods
Administration (https://www.tga.gov.au/).
For EU: Users and/or patients within the European Union, should report
any serious incident that has occurred in relation to the device to the
manufacturer and the competent authority of the Member State in which
the user and/or patient is established. Users outside of the European Union
should report any serious incident that has occurred in relation to the device
to the manufacturer and the regulatory authority of the country in which the
user and/or patient is established.
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