Events

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

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 MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET CRITICAL CARE.

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
    1582
  • Date
    2015-05-25
  • 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
    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.
  • Cause
    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
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    ANVSANVISA