Alerta De Seguridad para CONTINUUM INFUSION SYSTEM, MIK codes 200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, 3015160 and 3015161. Anvisa Registry No. 80172890011.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medrad do Brasil; Equip. Prod. Sáude e Serviços Técnicos 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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    According to the record holder, the accuracy of the Continuous Infusion system is defined in the product specification contained in the operating manual (+/- 10% +/- 2C). Technical complaints received by the company claim sub-dose and root cause analysis determined variations in infusion characteristics attributed to variation in elasticity property and resistance of the connectors, which can directly affect system performance. Tests performed indicate that the connector exhibits a higher glass transition temperature and is significantly more rigid at room temperature, resulting in a material having an undesirable elastic property and which, when used as part of an infusion mechanism, exhibits significant variation relative to the flow rate accuracy (outside the accuracy limit of +/- 10%). A risk study was conducted by the company to evaluate technical complaints and there are two risk scenarios associated with this situation: Scenario 1: The operator realizes that the patient is not receiving the volume and flow rate programmed during or after the procedure. The completion of this risk assessment has an unacceptable level of safety; Scenario 2: The Biomedical engineer examines the accuracy of the pump before performing the procedure and based on the error presented the procedure is not performed. The completion of this scenario is within acceptable security level. For additional information, consult the alert message issued by the company at
  • Causa
    The equipment may be infusing a smaller than expected volume (sub-dose).
  • Acción
    Users are required to segregate the device, fill out a form stating the quantity of affected products in their inventory, send a communication letter (with completed form) to the registration holder and make the affected products available for withdrawal at the institution by the registration holder. The forms for communication to the company are available at


  • Empresa matriz del fabricante (2017)
  • Source