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This is duplicated text of a letter from
Abbott Laboratories, Limited.
Contact the company for a copy of any references, attachments or
enclosures.
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IMPORTANT SAFETY INFORMATION REGARDING THE USE
OF SEVORANE AF (SEVOFLURANE) IN CONJUNCTION WITH ANESTHESIA MACHINES
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November 17, 2003
Dear Healthcare Professional,
Abbott Laboratories, Limited ("Abbott") would like to make you aware
of rare, isolated reports of smoke/fire or extreme heat which have been
observed in anesthesia machines where SEVORANE AF* (sevoflurane)
is used in conjunction with a desiccated carbon dioxide (CO2)
absorbent. Although ongoing investigations have not yet identified the
exact etiology, Abbott considers it important to inform anesthesia providers
of the existence of these rare occurrences, which can result in patient
injury.
Based on available information, it is important to highlight that in
most cases reported to Abbott, desiccated CO2 absorbents were
in use. It is also well documented that the exothermic reaction that occurs
between all inhalational agents, including sevoflurane, and the CO2
absorber is increased when the absorber becomes desiccated, such as after
an extended period of dry gas flow through the absorbent canister.
Please remember to continue to follow your best practices with respect
to maintaining your anesthesia machines, such as:
- If you suspect that the CO2 absorbent may be desiccated
because it has not been in use for an extended period of time, replace
it.
- Although the exact conditions under which absorbent may become desiccated
are not well defined, a low fresh gas flow rate over an extended period
of non-use may contribute to unexpected desiccation of CO2
absorbent materials on the anesthesia machine. Therefore, completely
shut off the anesthesia machine at the end of clinical use or after
any case when a subsequent extended period of non-use is anticipated.
- Turn off all vaporizers when not in use.
- Verify the integrity of the packaging of new CO2 absorbents
prior to use.
- Periodically monitor the temperature of the CO2 absorbent
canisters.
- Monitor the correlation between the sevoflurane vaporizer setting
and the inspired sevoflurane concentration. An unusually delayed rise
or unexpected decline of inspired sevoflurane concentration compared
to the vaporizer setting may be associated with excessive heating of
the CO2 absorbent canister.
In addition, please consider the following:
- The colour indicator of most CO2 absorbents does not necessarily
change as a result of desiccation. A lack of significant colour change
should therefore not be taken as an assurance of adequate hydration.
CO2 absorbents should be replaced routinely regardless of
the state of the colour indicator.
- If excessive heat from the CO2 absorbent canister is noted,
the clinical situation should be evaluated and disconnecting the patient
from the anesthesia circuit should be considered.
- The following findings have been reported in association with the
rare events of fire and extreme heat:
- Failed inhalation induction or inadequate anesthesia with sevoflurane
- Patient signs of airway irritation, such as coughing
- Oxygen desaturation, increased airway pressures, and difficult
ventilation
- Severe airway edema and erythema
- Elevated carboxyhemoglobin levels
- Current information indicates that typically these cases of fire or
extreme heat were the first case of the day for the specific anesthesia
machine, and the reported cases indicated that Baralyme®
CO2 absorbent was used. However, cases of extreme heat have
been reported in association with desiccated soda lime.
- When desiccated CO2 absorbents are used with sevoflurane
under extreme experimental conditions, flammable degradation products,
including formaldehyde and methanol, may be present even in the absence
of fire. The potential risk to patients receiving sevoflurane anesthesia
due to these breakdown products has not been evaluated.1
Similar to other potent inhalational anesthetic agents, sevoflurane,
when exposed to desiccated CO2 absorbents, produces carbon
monoxide.2
SEVORANE AF* (sevoflurane) has been available in Canada
since its initial launch in 1995. Although these events are rare and isolated,
they can result in patient injury. Abbott will continue to investigate
the causative and preventive factors surrounding the issues of fire, extreme
heat, and potential breakdown products associated with the use of sevoflurane
and desiccated CO2 absorbents. Abbott will continue to provide
timely guidance as relevant information becomes available.
Please review the steps to reduce the risk of fire and extreme heat included
in this letter with your anesthesia associates. As with all medical products,
healthcare professionals are strongly encouraged to report any adverse
events that occur with the use of SEVORANE AF*. If you
have additional questions regarding SEVORANE AF*, please
contact Abbott Laboratories, Limited.
Sincerely,
original signed by
Mauricio Ede, MD, PhD
Medical Director
Abbott Laboratories, Limited
* TM
References:
- Holak EJ, Mei DA, Dunning MB III, et al. Carbon
monoxide production from sevoflurane breakdown: modeling of exposures
under clinical conditions. Anesth Analg. 2003;96:757-64.
- Wissing H, Kuhn I, Warnken U, Dudziak R Carbon monoxide
production from desflurane, enflurane, halothane, isoflurane, sevoflurane
with dry sodalime. Anesthesiology 2001;95:1205-12.
Abbott Laboratories, Limited/Laboratoires Abbott, Limitée
P.O. Box/C.P. 6150, Station/succursale Centre-ville
Montréal (Québec) H3C 3K6
Any suspected adverse incident can also be reported to:
Health Products & Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
OTTAWA, Ontario, K1A 0K9
Tel: The Medical Devices Hotline 1-800-267-9675
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