Events

Safety Alert for Carbon Dioxide Absorbers in Anesthesia (1) Unit of Carbon Dioxide Absorbents (Anesthesia Unit Carbon Dioxide Absorbents); (2) Anesthesia Unit Carbon Dioxide Absorbers; (3) Circulated Anesthesia System.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    225
  • Date
    2000-12-15
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    There are references to various incidents of patient exposure to carbon monoxide (co) and an incident of injury to the patient has been reported. ecri continues to receive calls about this topic and has updated the original article. ecri states that co is produced when halogenated anesthetic agents come into contact with commonly used co 2 absorbers that are extremely dry due to hospital gas flow during prolonged periods of inactivity of anesthesia equipment. based on investigations, ecri concluded that hazardous levels of co were produced within systems under conditions which included the presence of excessively dry co 2 absorbers and were used to provide halogenated anesthetic agents during the first day surgery, fairs ecri states that similar incidents are reported in the medical literature, with co exposure time being a common feature.
  • Action
    ECRI makes the following recommendations: (1) Inform the anesthesiologists and other staff involved about the problem and the ECRI report. (2) Make sure all hospital gases have been closed when the anesthesia system is not to be used immediately for another procedure. At the end of the day, make sure all hospital gases are closed in all anesthesia systems. (3) Before using the anesthesia system in the first case of the day, make a pre-use check, check for any hospital gas flow. If so, replace the absorber in both filters before using the system. Also, identify and address the cause of the hospital gas flow. For more information, contact your local representative.

Device

Carbon Dioxide Absorbers in Anesthesia (1) Unit of Carbon Dioxide Absorbents (Anesthesia Unit Car...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA