Events

Alerta De Seguridad para Infusomat Space Set Air IL (Non-photosensitive equipment for infusion of parenteral solutions into infusion pumps) - Code 441702 - Registration 80136990755 - Lots 15G21LA335, 15H21LA383, 15H21LA384, lSH24LA385 and 15H31lA398 and Enteral Nutrition Equipment for infusion pumps B.Braun (Infusomat Space Set Enteral Air) Code 402111 - Registration number 80136990733, lot 15H2SLA388

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..

¿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
    1697
  • Fecha
    2015-10-09
  • 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
    According to the manifestation of the company, this condition can compromise the correct functioning during the removal of the pump equipment, which can result in free flow, in case the health professional does not perform the standard procedure, which consists of closing the clamp and disconnect the patient's equipment before removing it from the pump.
  • Causa
    During an inspection by the production supervisor (assembly area), the erroneous assembly of the green infusomat clamp component was identified by a specific employee. although the employee was trained, he was assembling the tongs inverted. 100% of the employee's production was inspected and the problem was confirmed.
  • Acción
    The company is carrying out the collection of the lots mentioned in this alert and requests the interruption of the use of said batches, the segregation thereof, as well as the information to the B. Braun SA laboratories of the quantities of existing units of each batch number for the process of recollection

Device

Infusomat Space Set Air IL (Non-photosensitive equipment for infusion of parenteral solutions int...

Manufacturer

Laboratórios B. Braun S.A.