Alerta De Seguridad para Trade Name: HEMODIALISE BELLCO MACHINE Technical Name: Hemodialysis Device ANVISA Registration Number: 80102510346 Hazard Class: III Model Affected: FORMULA; FORMULA 2000; FORMULA 2000 PLUS; FORMULA PLUS; FORMULA THERAPY

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR MEDICAL LTDA; AUTO SUTURE DO BRASIL LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2159
  • Fecha
    2016-11-17
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Identify if your Formula hemodialysis machine has backup battery. If there is a backup battery in your machine, the following label is located on the back panel of the machine. For machines with backup battery, see Appendix A. This annex describes the procedure for disconnecting the battery Formula with spare battery, driven by a qualified technician. In addition, refer to Appendix B for access to the available instructions for operating the machine in the event of power failure. It is worth noting that in cases of power failure or interruption without reserve battery, the Formula line machine will go into failure mode, causing the blood pump to stop working. Carefully read the instructions for using manual blood circulation to ensure safe operation during a long period of power failure. In the case of machines with no backup battery, please refer to Appendix C. This appendix describes the procedure for disconnecting the battery pack from the Formula line without reserve battery by a qualified technician.
  • Causa
    Three events were 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. we note that disconnecting the battery charge frame eliminates the possibility of failure mode while a permanent solution is being implemented.
  • Acción
    Field Action Code AC05 triggered under the responsibility of the company VR MEDICAL LTDA. Company will update, correct or supplement the instructions for use.

Manufacturer