Events

Alerte De Sécurité sur 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

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 VR MEDICAL LTDA; AUTO SUTURE DO BRASIL LTDA.

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
    2159
  • Date
    2016-11-17
  • 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
    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.
  • Cause
    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.
  • Action
    Field Action Code AC05 triggered under the responsibility of the company VR MEDICAL LTDA. Company will update, correct or supplement the instructions for use.

Device

Trade Name: HEMODIALISE BELLCO MACHINE Technical Name: Hemodialysis Device ANVISA Registration Nu...

Manufacturer

VR MEDICAL LTDA; AUTO SUTURE DO BRASIL LTDA
  • Source
    ANVSANVISA