Events

Alerte De Sécurité sur Trade name: HEMODIALISE BELLCO MACHINE /// Medical Product Model: FORMULA 2000, FORMULA 2000 PLUS, FORMULA PLUS and FORMULA THERAPY. ANVISA Registration Number: 80102510346 / / / Risk Class: III - High Risk /// Affected Model (s): All models mentioned above. // series: vide portal Anvisa - Alert 2048.

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 AUTO SUTURE DO BRASIL LTDA; Bellco S.R.L..

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
    2049
  • Date
    2016-11-18
  • 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
    0
  • Cause
    Hemodialysis device - three events have been reported that resulted in fire on three different machines; during the disinfection cycle of one of the machines and before use in the patient on two machines, which were connected. based on internal investigations at the company bellco srl, it was determined that the battery charge frame would be the source of the problem in two of these events. the source of the problem in the third machine could not be definitively determined because of the magnitude of the damage in the frame, although the available evidence is consistent with the other two events. the manufacturer has found that disconnecting the battery charging frame eliminates the possibility of failure mode while a permanent solution is being implemented.
  • Action
    Risk classification: III.///Classification of the field action: Update, correction in the field. Update, field correction and subsequent recall, where the products will be exported to Memphis later. / / Field action code: AC05 /// Recommendations to users and patients: The applicable Shares are described in Attachments A, B and C issued by the manufacturer and may be carried out by the technician of the acquiring company or through the Technical Assistance of MEDNEX BRASIL, Rua Sampaio Viana, 277 - 9 ° andar, CEP 04004-000 - Paraíso, São Paulo - SP, Phone: + 55 11 2039-1330 company is authorized and trained by the manufacturer Bellco.

Device

Trade name: HEMODIALISE BELLCO MACHINE /// Medical Product Model: FORMULA 2000, FORMULA 2000 PLUS...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Bellco S.R.L.
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA