Alerta De Seguridad para VOLUMETRIC INFUSION PUMP COLLEAGUE - Anvisa Record n ​​° 10068390320. All models (Mono and Triple Channel).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Hospitalar 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
    On May 3, 2010, the US Food and Drug Administration (FDA) ordered the Baxter company to perform the recall and destruction of Colleague Infusion Pump equipment currently in use in the United States. According to the FDA and Baxter, the imposition of the recall was not motivated by any risk attributed to the product. The reason for the payment was the company's failure to comply with the deadline to finalize corrective actions in the software of the equipment marketed in the United States. The FDA has not yet set the deadline for the recall and together with Baxter discusses the best strategy in order to minimize problems for patients and not affect their safety. Baxter is expected to submit a written plan to the FDA by the end of May 2010. Anvisa requested the product registration holder (Baxter Hospitalar Ltda, Baxter's Brazilian subsidiary) to provide information on the situation of Colleague pumps in Brazil. According to the company, imported Colleague pumps (about 5,700 units) received software updates that were not implemented in the US. According to the company, these fixes solve problems in the equipment. In the medium term, Baxter Hospitalar Ltda will replace the software version of Colleague pumps with a new version (see P.1.7). Version P.1.7 will be finalized by 2011 and, after Anvisa's approval, will be implemented in all equipment commercialized in Brazil. Anvisa is monitoring the developments of the case with Baxter Hospitalar Ltda and has not yet determined the collection of Colleague infusion pumps commercialized in the country. The implementation of the measures by the company is being checked (software replacement) To date, there are no notifications of adverse events or technical complaints involving the product in Brazil. The case is being accompanied by the Technovigilance Unit (UTVIG / NUVIG / ANVISA) and new information will be released as soon as it is available. #### UPDATE: The field correction was completed by the company on 10/30/2014. According to the company, 7,731 units were corrected (out of a total of 8,943 units) - of 1,212 uncorrected equipment, 1,083 were not located by the company and 129 had no external movement (movement without "low" termination in the company's system).
  • Causa
    Equipment collection colleague infusion pumps determined by the food and drugs administration (fda), applicable only to the usa.
  • Acción
    To date, there is no evidence that the use of Colleague infusion pumps (Baxter company) in Brazil has been interrupted.


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