Events

Alerta De Seguridad para (B) Code 4440008 - EASYPUMP C-BLOC RA 400ML 2-14mL / h PCA 5mL / h PCA 5mL / h PCA 5mL / h PCA 5mL / h . Lots Affected: (a) Code 4440006: Lot no. 142639 and (b) Code 4440008: Lot no. 152803 and 192472.

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
    1233
  • Fecha
    2013-03-01
  • 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
    The company states that the I-Flow tests and the historical review of complaints have determined that about 0.04% of the pumps (4 out of 10,000 pumps) may have the described condition. If such a condition occurs, it may not be detected during the filling or priming of the pump. Anvisa follows this field action.
  • Causa
    When using i-flow elastomeric pumps with an on demand function, the bolus button may not lock in the lower position when pressed and either the orange bolus reset indicator may remain in the lower position. thus, the patient can receive continuous infusion at a flow greater than expected.
  • Acción
    Immediate interruption of use of said products / lots; segregation thereof and information to B. Braun SA Laboratories of the quantities of existing units of each product code and batch number. Phone to contact: (21) 2602-3263 - jose.ricardo@bbraun.com.

Device

(B) Code 4440008 - EASYPUMP C-BLOC RA 400ML 2-14mL / h PCA 5mL / h PCA 5mL / h PCA 5mL / h PCA 5m...

Manufacturer

LABORATÓRIOS B. BRAUN S/A