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K/2c3. Pleura Autotransfusion Systems Traditional 510(k) Section 8 Summary of Safety and Effectiveness 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DEC 10 2012 Pleura Autotransfusion Systems A. Name,

How to fill out pleurevac autotransfusion systems

How to fill out pleurevac autotransfusion systems:

1. First, ensure that you have a clean and sterile environment to work in. This is crucial to maintaining the integrity of the system and preventing any contamination.
2. Start by locating the collection chamber of the pleurevac autotransfusion system. This is where the blood or fluid will be collected from the patient.
3. Attach the appropriate collection tubing to the collection chamber. This tubing will typically have a filter to remove any debris or clots from the collected fluid.
4. Connect the other end of the collection tubing to the patient's chest tube or drainage site. Make sure that the connection is secure to prevent any leaks.
5. Once the tubing is properly connected, you can start the suction or vacuum source. This will create negative pressure within the system and help to collect the fluid.
6. Monitor the collection chamber and adjust the suction level as needed. It is important to maintain the proper suction pressure to effectively collect the fluid without causing any harm to the patient.
7. Periodically check the collection chamber for any clots or debris that may have accumulated. If necessary, gently agitate the collection chamber to dislodge any trapped material.
8. As the fluid collects in the chamber, you may need to empty or drain it to prevent overflow. Follow the specific instructions provided by the manufacturer for emptying the collection chamber.
9. Once the collection process is complete, carefully disconnect the collection tubing from the patient's chest tube or drainage site. Dispose of any used or contaminated materials properly.

Who needs pleurevac autotransfusion systems:

1. Pleurevac autotransfusion systems are commonly used in thoracic surgeries, particularly those involving the lungs or pleural space. They are also used in cases of chest trauma or injury that may result in the accumulation of blood or fluid in the chest cavity.
2. These systems are designed to collect and reinfuse the patient's own blood or fluid to minimize the need for external blood transfusions. This is particularly beneficial for patients who may have medical contraindications to receiving donated blood, or for those who require a large volume of blood replacement.
3. Pleurevac autotransfusion systems can also be used in certain medical conditions such as pleural effusion, hemothorax, or pneumothorax, where fluid or air accumulates in the pleural space and needs to be drained.

In summary, pleurevac autotransfusion systems are used to collect and reinfuse a patient's own blood or fluid, primarily in thoracic surgeries or cases of chest trauma. By following proper filling procedures, these systems can effectively collect and manage fluid accumulation in the chest cavity.

For pdfFiller’s FAQs

What is pleurevac autotransfusion systems?

Pleurevac autotransfusion systems are medical devices used to collect and reinfuse a patient's own blood during surgery.

Who is required to file pleurevac autotransfusion systems?

Healthcare facilities and providers who use pleurevac autotransfusion systems are required to file reports.

How to fill out pleurevac autotransfusion systems?

The reports for pleurevac autotransfusion systems can be filled out electronically or on paper, following the specific instructions provided by regulatory authorities.

What is the purpose of pleurevac autotransfusion systems?

The purpose of pleurevac autotransfusion systems is to reduce the need for allogeneic blood transfusions and associated risks.

What information must be reported on pleurevac autotransfusion systems?

The reports for pleurevac autotransfusion systems must include information on the number of procedures performed, amount of blood collected and reinfused, and any adverse events.

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