Events

Alerta De Seguridad para FLOW-i Anesthesia System. Anvisa Registration n ° 80259110040. All serial numbers up to 2753.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET CRITICAL CARE.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1582
  • Fecha
    2015-05-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Maquet discovered from the complaint records that the PATIENT cassette can be accidentally moved when the CO2 absorber is replaced or when the patient tubes are replaced. If such a cassette is moved while the equipment is running, air leakage may be identified due to a large discrepancy between the inspired and expired tidal volume. The clinical consequence will be the cessation of ventilation. See additional information in the Company's Alert Message, available at http://portal.anvisa.gov.br/wps/wcm/connect/026d2480488daa82a6edeefd7a12d53b/Message+of+Alerta+1582.pdf?MOD=AJPERES. ### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Risk of leakage due to accidental displacement of the patient cassette.
  • Acción
    Maquet do Brasil will take corrective action in the field in loco, in the clients that own the products at risk. Product users are advised to always make sure that the appropriate alarm has been selected and to check the tidal volume differences between inspiration and expiration. Excessive force should be avoided when changing patient tubes or CO2 absorber; If this happens, the patient cassette should be pressed back into position, thereby closing the leak - such a procedure can be done quickly, without the need to turn off the equipment.

Device

FLOW-i Anesthesia System. Anvisa Registration n ° 80259110040. All serial numbers up to 2753.

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET CRITICAL CARE
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    ANVSANVISA