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PakuMed Port GKat GW 5991 gport label

PakuMed Port GKat GW 5991 gport label

Product description

portg deThe TITAN-PORT GONE FOR ALL NEEDLES, ALL FOR ONE PORT .

Port puncture now possible with all needles!

  • cost savings by using "normal" needles for puncture
  • technical failures excluded –> safety increased
  • no punch defects in the port membrane

TITAN-PORT System G are totally implantable port catheter systems consisting of an injection chamber (port), a screw closure machanism, a self-sealing silicone membrane and a catheter. Each system includes a special access needle, a dilatator, catheter introducer, these instructions for use and a patient ID-card. Some sets contain introduction instruments and tunnelizers.

The port chamber consists of hypoallergenic biocompatible titanium. This material is non-magnetic. The base plate has openings for securing the system with sutures to the fascia. The port chamber and the catheter can be disconnected.

The silicone membrane can be punctured up to 3000 times with the enclosed non-coring special puncture needle. The membrane possesses a high-pressure stability and ensures proper positioning of the needle when placed.

The catheter (various models, sizes and materials depending on indication) can be shortened to the individual length required. It bears radiopaque calibration markings at 5 cm intervals, and is conically tapered at the tip. The arterial catheter has three distal fixation rings. The same applies to PUR (Polyurthane) Catheters.

The patient ID-card is filled out by the doctor who performed the implantation and is given to the patients who should always carry this document with them.

The instructions for use should also be available to nurses and doctors responsible for follow-up care.

Product specifications and serial number are listed in the catalogue. The contents of the product are labelled on each sterile package.

instruction for use

INDICATIONS
The TITAN-PORT-Systems ensure repeated access to the vascular system for the following indications:.

  • long-term venous access
  • systemic chemotherapy
  • administration of medications
  • regional chemotherapy
  • pain therapy
  • blood sampling, poor vascular status
  • long-term infusion therapy and parenteral nutrition

CONTRAINDICATIONS
The TITAN-PORT systems should not be used in:

  • Extremely rare cases of hypersensitivity to silicone, polyurethane or titanium
  • suspected bacteremia or sepsis
  • disseminated intravascular coagulation (DIC)

COMPLICATIONS and potential ADVERSE REACTIONS
UThe following complications or adverse reactions can occur:

  • Technical intraoperative complications
  • Tissue incompatibility
  • Local reactions (inflammation, edema, hematoma)
  • Infection
  • Disconnection or dislocation
  • Thrombosis / thromboembolism
  • Breakage of the catheter between the clavicle and first rib
  • Breakage of catheter or damage to catheter
  • Membrane leakage
  • Perforation of catheter
  • Drug extravasation due to improper handling of the system
  • Damage to neighboring tissues by the pharmaceutical agents
    (In the event of leakage of portal components)

INSTRUCTIONS FOR USE / PORT IMPLANTATION
Caution: During implantation sterile handling is absolutely mandatory!

  • Various techniques are available for implantation of port and catheter, including the Seldinger technique

The choice depends on the surgeon's preference

  • The implantation of TITAN-PORT A/V, P and S is usually possible under local anesthesia, TITAN-PORT D, PD, PC under general anesthesia (see special instructions for use)
  • Recommended sites for venous catheter placement include the cephalic vein, subclavian vein, or internal and external jugular veins.
  • Use a 10 ml syringe and only special non-coring needles for puncturing the septum. The needles are intended for single use only.
  • The needle should be inserted into the silicon membrane carefully and always vertically to avoid bending the tip.

If the situation is unclear or thrombotic obstruction is suspected a radiographic or Doppler sonographic control is necessary. To achieve greater flow rates the port membrane may be accessed simultaneously with up to three needles.

  • A venous implantation should be flushed once every 3 months.
  • An arterial implantation requires flushing once every 2 week.
  • For sampling venous blood 3 ml of blood should initially be aspirated and discarded. A 20 G needle should be used and the required amount of blood aspirated slowly to avoid haemolysis and falsification of the results. *Note: 18 G or 19 G needle is recommended for blood transfusions.
    Afterwards the system must be flushed immediately with a heparinized saline solution. During the flushing procedure the needle may be rotated in different directions to ensure uniform rinsing of the chamber interior.
  • To avoid interactions between various drugs (cytostatic agents in particular) the system must be flushed with 5-10 ml 0.9% saline when repeated infusions are required.
  • The system must be flushed after each use. The needle is removed with gentle force.
  • Catheter obstruction due to thrombus formation can usually be cleared by injecting Streptokinase / Urokinase (e.g. 5000 IE / ml physiologic saline in a 10 ml syringe). Small amounts should be injected at intervals, allowed time to take effect, and then patency checked.
    (The above-mentioned concentrations are recommendations and must always be adapted to patient's coagulation status as monitored by a physician. The product description of all pharmaceuticals used should always be consulted.)
  • The complication rate of thrombus formation in the catheter can be reduced in patients at risk by low-dose heparinization or, in arterial portal systems, by the administration of a platelet aggregation inhibitor (e.g. acetylsalicylic acid).

CAUTION
Causes of abnormally high resistance to access needle may include

  • Incorrect placement of the access needle in the portal chamber
  • bending and kinking of the catheter
  • Fibrin deposition or thrombotic occlusion of catheter or port.

Blood deposits in the system generally indicate faulty handling, leakage or a defective septum inside the port.
When blood aspiration is not successful, the port should be flushed and the patient's position changed.


INDICATIONS FOR EXPLANTATION

The port can be removed under local anesthesia at the end of treatment. Other indications include:

  • Irreversible obstruction of the portal system
  • Infection of the portal system
  • Breakage of catheter or damage to catheter
  • Membrane leakage
  • Poor patient compliance
  • Massive thrombosis of the major vessels (subclavian vein, v.cava)
  • Uncontrollable infection (port removal only under general anesthesia)

WARNINGS

  • The port should be secured to surrounding subcutaneous tissue by sutures or placed in the smallest of portal pockets in order to prevent port migration.
  • The catheter must be secured to the vein with a firm, but not constricting suture.
  • The proper connection of the catheter to the port should be confirmed.

PRECAUTIONS
Sterility

Meticulous hygiene and sterile handling technique are mandatory for the safe usage of TITAN-PORT Systems.This includes:

  • Implantation in sterile OR setting
  • Proper disinfection of hands and skin
  • Sterile gloves when initiating treatment
  • Use of sterile products

AFTERCARE AND MONITORING

Regular treatment sessions and associated care of the port system are coincidental with monitoring of the port system.
Port systems should not be used by physicians / health care personnel not familiar with all aspects of the product and its potential complications. Complications can occur at any time during and after implantation.

Technical data

 Art.Nr. Port Catheter     PZN
  Material Base Height
Septum Ø Weight
Material OD ID Length French  
111248 G-SET* Titanium 28 mm 13,4 mm 12 mm <16 g Silicone 2,5 mm 1,2 mm 700 mm 7,5 06149298

*including introducer set and tunnelizer

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