Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET CRITICAL CARE.

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
    1582
  • Date
    2015-05-25
  • 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
    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.
  • Reason
    Risk of leakage due to accidental displacement of the patient cassette.
  • Action
    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
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    ANVSANVISA