Events

Alerta De Seguridad para Infusomat Compact - Infusomat Compact Infusion Pump / Infusion Pump Technical Name: Infusion Pump ANVISA Registration Number: 10008530367 Hazard Class: III Model Affected: Infusomat compact

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laboratórios B. Braun S.A.; Laboratórios B. Braun S.A..

¿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
    2182
  • Fecha
    2016-11-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    To take measures to ensure the safe use of the units of equipment belonging to the serial numbers involved in this field action, proceeding, in case of need of change of flow during therapy, using the "titration" function, as described in the User Manual, Rev. 10 page 30. Then, fill in the data contained in the field action notification letter and notify B. Braun Laboratories that software 4.00 will be replaced by software 3.05.
  • Causa
    There were three situations of undesired operation in infusomat compact devices with software version 4.00 (sw 4.00), as described below: 1. when it is desired to change the flow through the "c" key with the infusion in progress as described in the manual the user, rev.10. p. 30, the number key "8" is inhibited, ie when this key is pressed, the digit 8 is not added to the flow value. however, due to the need to change the flow rate to increase or decrease it, according to medical prescription, during the infusion, the titration function (described in the user manual rev.10 page 30) can be used without any difficulty, taking into account need for infusion therapy. titration is the most recommended and used procedure in hospital practice. 2. when the equipment is switched on and then a drug is selected without programming or starting the infusion, the device does not allow the flow to be programmed without the "c" key being pressed. only the numeric keys 7, 8, 9 and 0 are expected to function without the "c" key being pressed. 3. if the infusion is intentionally interrupted or programmed without the infusion being started / started by the start key, after four minutes the device sounds a continuous alarm (expected only in case the pump is awaiting infusion start) and after a few seconds it starts to emit repetitive beeps.
  • Acción
    Field Action Code AC / 05/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will make correction in the field.

Device

Infusomat Compact - Infusomat Compact Infusion Pump / Infusion Pump Technical Name: Infusion Pump...

Manufacturer

Laboratórios B. Braun S.A.; Laboratórios B. Braun S.A.