Events

Alerte De Sécurité sur Negative Pressure Wound Therapy Pump Extricare 2400, Model EC2400-E, Registration 80047309100, Lot 41513 // Extricare 2400 Bandages, Models EC2400-LO-E; EC2400-SO-E; EC2400-SE; EC2400-HE; EC2400-MN-E; EC2400-IM-E; EC2400-FE, Registration 80047300462, lot 41523

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 MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; Devon Medical Products.

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
    1570
  • Date
    2015-04-28
  • 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
    The various modes of failure of the ExtriCare and the complaints were presented to a panel of three independent external medical specialists (March 19, 2015, Herlev University Hospital, Copenhagen, Denmark) for the purpose of obtaining an external assessment of the related safety concerns with the use of ExtriCare. The experts confirmed the link between failure modes and risk for patients, based on their clinical experience and the literature. The malfunction of the ExtriCare NPWT system poses serious risks to patient safety in terms of localized infections, systemic infections (sepsis), and delayed wound healing.
  • Cause
    The company responsible for product marketing received some notifications related to product problems, as follows: vacuum lack or instability from the pump, stagnation of the wound exudate in the tubing while the npwt system is in operation, and reflux of the exudate of the wound from the tubing and reservoir to the wound while the npwt system is in operation. / 2) leakage of the pipe from the suction port. / 3) leakage of air from the suction port. / 4) leaking air from the suction port and detaching the tubing from the suction port.
  • Action
    The company advises customers to perform the inventory review and separation of the affected products for recall. Further information: sac@medstar.com.br

Device

Negative Pressure Wound Therapy Pump Extricare 2400, Model EC2400-E, Registration 80047309100, Lo...

Manufacturer

MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; Devon Medical Products
  • Source
    ANVSANVISA