Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    226
  • Date
    2000-12-15
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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...
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA