Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AUTO SUTURE DO BRASIL LTDA; Bellco S.R.L..

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
    2049
  • Date
    2016-11-18
  • 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
    0
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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