Indications; Contraindications; Potential Complications (Immediate And Delayed); General Warnings & Precautions - B.Braun CELISTE Instrucciones De Uso

III - INDICATIONS
Celsite® Access Ports are indicated for patient therapies requiring repeated access to the vascular system.
• Celsite®/Celsite® Concept
and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.
Discreet TM
• Celsite® / Celsite® Dual Venous / Celsite® Brachial / Celsite® Babyport® / Celsite® Babyport® S Ports are recommended
for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.
IV – CONTRAINDICATIONS
The following are contraindications to port placement:
• Known infection, bacteraemia or septicemia.
• Known allergy to any of the materials contained in the access port or catheter.
• If the medications to be used in the access port are incompatible with any of the materials contained in the access port or
catheter.
• If the patient's anatomy does not allow the insertion of the catheter into the chosen access site.
• Blood clotting disorder.
V – POTENTIAL COMPLICATIONS (Immediate and delayed)
Air embolism
Brachial plexus injury
Cardiac arrhythmia, tamponade, puncture
Catheter disconnection or fragmentation
Catheter occlusion
Catheter rupture
Embolism
Explantation of the port secondary to
inflammatory reaction
Fibrin sheath formation
Hematoma
Hemothorax
Hemorrhage
Before implantation of the access port system these, and other, well documented potential complications should be considered.
VI - GENERAL WARNINGS AND PRECAUTIONS
VI-1 HANDLING AND STORAGE
Precautions:
• This product should be implanted or accessed only by personnel experienced in the technical and clinical aspects of access ports.
• During storage avoid freezing or excessively high temperatures, storage at room temperature is recommended.
• Celsite® Access Ports are for single use only, do not re-sterilize the product, or any of the components, and destroy after use. The
product is sterilized using Ethylene Oxide and is sterile and non-pyrogenic in unopened, undamaged, individual packages. Do not
use if package is damaged.
• Check the expiration date before use and never implant a device past the expiration date.
VI-2 PATIENT
Precautions:
• Ensure that use of the access port is indicated taking into consideration the patients' anatomy, needs and proposed use of the port.
• Check the condition of the skin over the proposed implantation and puncture sites.
• For venous catheter placement, place the patient slightly inclined head down.
• Check hemostasis: Partial thrombin, Partial thrombin time, Bleeding time, Platelet count.
VI-3 CATHETER POSITION
Precaution: To ensure that the system works correctly, there should be no kinking of the catheter.
It is recommended that the catheter is tunnelled sub-cutaneously to the port.
VI-4 DRUG INCOMPATIBILITIES
Precaution: Do not use drugs or solvents which are incompatible with the raw material of the catheter.
Never use incompatible drugs together or in sequence: the port should be rinsed of all residues with 10-20 mL sterile sodium
chloride (NaCl) 0.9% between each medication.
VI-5 NEEDLES
Precautions: Always use special bevelled needles which are adapted for use with implantable access port systems.
Normal hypodermic needles will damage the septum and may cause leakage of the system or blockage due to small silicone particles.
Care must be taken to avoid needle sticks in accordance with local Infection Control standards (and avoid the risk of exposure to
contaminated blood).
TM
Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics
Infection/Sepsis
Pneumothorax
Port/Catheter migration
Thromboembolism/Thrombophlebitis
Thrombosis
Fever, chills, or other flu-like symptoms
Swelling, pain, pus, redness or burning sensation
around the port incision
Shortness of breath or dizziness
Chest pain
Pain or swelling of neck, face, or arm on side of
body where the implantable port is inserted
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