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FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices

Posted Jul 08 2010 9:00pm

Date Issued: July 9, 2010

Audience: Surgeons, Operating Room Nurses, and other support personnel in the Operating Room

Products:

Air- or gas-pressurized sprayers are dual syringe products that simultaneously mix and apply two non-homogeneous liquids within a single spray head that is connected to a pressure regulator and a source of compressed air or gas. Air- or gas-pressurized sprayers can be used to mix and apply hemostatic drug or biological products (products that help control bleeding from blood vessels during surgery) including fibrin and non-fibrin sealants.

They include devices such as:

  • EasySpray and spray set used with Duploject system(Baxter Healthcare Corporation)
  • Tissomat and spray set used with Duploject system (Baxter Healthcare Corporation)
  • Evicel application device (Omrix Medical)
  • FibriJet Aerosol Applicator (MicroMedics)
  • HemaMyst Surgical Applicator System (Heamacuare Corporation)
  • MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)
  • Vitagel Hemostat Spray Set (Orthovita, Inc.)

Summary of Problem and Scope:

FDA has received reports of air or gas embolisms occurring during or immediately after application of hemostatic drug or biological products using air- or gas- pressurized sprayers. Although rare, the reports describe air embolisms that are life threatening and include one fatality.

These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site.

Recommendations/Actions:

Given the life-threatening consequences of an air or gas embolism, FDA is recommending that clinicians using air- or gas- pressurized spray devices for application of hemostatic drug or biological products:

  • Use the applicator, spray set, and pressure control device or regulator as recommended in the labeling or Information For Use (IFU) of the hemostatic agent.
  • Use an air or gas pressure setting within the range recommended by the manufacturer of the sprayer.
  • Ensure that distance between the spray head and the tissue surface is not less than the minimum recommended by the manufacturer of the sprayer.
  • Monitor blood pressure, pulse, oxygen saturation and end tidal CO 2 for signs of an air or gas embolism.
  • Make sure the regulators are maintained properly and checked for safe performance regularly.

FDA Activities:

In cooperation with the FDA, Baxter Healthcare Corporation and Omrix Pharmaceuticals, the manufacturers of all fibrin sealants licensed in the U.S., have updated the Warning and Precautions sections of the labels of EVICEL, T isseel and ARTISS to emphasize the risk of air embolism and the need to use the recommended ranges of pressure and distance.

The labeling of the spray devices and non-fibrin hemostatic drug or biological products also includes information on recommended pressures and distances.

Report Problems to FDA:

Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical products. If you suspect problems with the use of fibrin sealants and/or air or gas pressurized fibrin sprayers, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program .  Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements should follow the reporting procedures established by their facilities.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@.FDA.HHS.GOV or 800-638-2041.

    
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