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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants (Baxter Healthcare Corporation)

05 October 2009

IMPORTANT DRUG WARNING

SUBJECT:    Risk of Life-Threatening Air or Gas Embolism with the Use of Spray Devices Employing Pressure Regulator to Administer Fibrin Sealants

Concerned Baxter product(s): TISSEEL Fibrin Sealant
ARTISS Fibrin Sealant (Human)

Dear Healthcare Professional:

Baxter Healthcare Corporation, in cooperation with the U.S. Food and Drug Administration (FDA), would like to inform you of an important safety update to the WARNINGS/PRECAUTIONS, Application Precautions section (5.2) of TISSEEL Fibrin Sealant and ARTISS Fibrin Sealant (Human) prescribing information.  This safety update applies to all fibrin sealants.   

The existing Warning and Precaution relating to the application of fibrin sealants has been updated to reflect a postmarketing report that demonstrates  a life-threatening risk of  air or gas embolism with the use of spray devices employing a pressure regulator to administer fibrin sealants.   This event appears to be related to the use of the spray device at higher than recommended pressures and  in close proximity to the surface of the tissue.

Specifically, the safety update includes the following instructions for sealant application using a spray device to help prevent air or gas embolism:

  • utilize spray pressure that is within the recommended guidelines by the device manufacturer
  • ensure that distance between the spray head and the application bed is within the recommended guidelines of  the device manufacturer
  • monitor patients for air or gas embolism

Fatality Reported for Evicel [Fibrin Sealant (Human)] Using a Spray Device at Higher than Recommended Pressure and in Close Proximity to the Surface of the Tissue.

The FDA has received a postmarketing fatality report in association with the use Evicel when applied using a spray device.  The case involved an attempt to stop active bleeding by applying Evicel using a spray device attached to a wall unit at a higher than recommended pressure for the spray device.  In addition, the spray head was placed at a distance from the bleeding site that was closer than the recommended distance guidelines for the application of the sealant.  The patient suffered a fatal air embolism.

Given the life-threatening and potentially fatal consequences of air or gas embolism, the WARNINGS/PRECAUTIONS, Application Precautions section (5.2) of TISSEEL and ARTISS prescribing information includes the following important safety update: 

5  WARNINGS/PRECAUTIONS

5.2  Application Precautions

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants.  This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. 

When applying fibrin sealants using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer.  In the absence of a specific recommendation avoid using pressure above 20-25 psi.   Do not spray closer than the distance recommended by the spray device manufacturer.  In the absence of a specific recommendation avoid spraying closer than 10-15 cm from the surface of the tissue.  When spraying the fibrin sealant, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.

In addition, the Highlights of the Prescribing Information has been updated as follows:

WARNINGS AND PRECAUTIONS

  • Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants.   This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue. (5.2)

The updated prescribing information for TISSEEL and ARTISS is enclosed. Please see the Indication and additional important risk information on page(s) 4-5 of this letter.

Should you have any questions regarding the use of TISSEEL and ARTISS require further information on product safety, or to report adverse patient experiences, please call our Medical Information Department at 1-866-424-6724.

Reporting Adverse Events to FDA

You are encouraged to report suspected adverse events, regardless of causality to FDA’s MedWatch reporting system

  • By phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178)
  • Online www.fda.gov/medwatch
  • Mailed, using MedWatch FDA 3500 postage paid form, to the FDA Safety Information and Adverse Event Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787

Sincerely,

Dr. Mark Bechter, BM
Senior Director
Global Clinical and Medical Affairs

Important Product Information for TISSEEL Fibrin Sealant

Indication
Hemostasis:  TISSEEL is indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical.   TISSEEL is a satisfactory hemostatic agent in fully heparinized patients undergoing cardiopulmonary bypass.

Sealing:  TISSEEL has been shown to be an effective sealant as an adjunct in the closure of colostomies.

Important Risk Information for TISSEEL Fibrin Sealant

Do not inject directly into the circulatory system.

Do not use in individuals with a known hypersensitivity to aprotinin.

Do not use for the treatment of severe or brisk arterial bleeding.

Apply only as a thin layer.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants.  This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue.

When applying fibrin sealants using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer.

Exposure to solutions containing alcohol, iodine, or heavy metals may cause TISSEEL to be denatured.

Safety and efficacy of TISSEEL alone, or in combination with biocompatible carriers, in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated or approved by FDA.

There have been rare reports of serious adverse events such as paralysis or other compressive complications possibly related to the use of fibrin sealant in combination with resorbable hemostatic agents.

This product is made from pooled human plasma which may, theoretically, contain infectious agents.

Please see accompanying TISSEEL Prescribing Information for full prescribing details.

Important Product Information for ARTISS Fibrin Sealant (Human)

Indication
ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations.
ARTISS is not indicated for hemostasis.

Important Risk Information for ARTISS Fibrin Sealant (Human)

For Topical Use Only.  Do not inject ARTISS directly into blood vessels.  Intravascular application of ARTISS may result in life-threatening thromboembolic events. 

Do not use ARTISS in individuals with a known hypersensitivity to aprotinin.

Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of ARTISS. 

Discontinue administration of ARTISS in the event of hypersensitivity reactions.

ARTISS is made from human plasma.  It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Apply as a thin layer.  Excessive clot thickness may negatively interfere with the product’s efficacy and the wound healing process.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants.  This event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue.

Exposure to solutions containing alcohol, iodine or heavy metals may cause ARTISS to be denatured.  If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of ARTISS and made as dry as possible.

Adverse reactions occurring in greater than 1% of patients treated with ARTISS were skin graft failure (5 events of 138 patients treated) and pruritus (2 events of 138 patients treated).

Please see accompanying ARTISS Prescribing Information for full prescribing details.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448