Alerta De Seguridad para Trade name: Volumetric Infusion Pump Colleague. Technical Name: Colleague Single Channel Cxe Pump English V1.7, Colleague Triple Channel Cxe Pump English V1.7, Colleague Single Channel Mono Chrome Pump, English V1.7, Colleague Triple Channel Mono Chrome Pump English V1.7. ANVISA registration number: 10068390320. Risk class: III. Affected Model: BRM91617, BRM91637, BRM81517, BRM81537. Serial number affected: 23040120UP; 25040009UP; 23050267DP; 23050472UP; 23020493DP; 25040027UP; 23020587DP; 23050460UP; 23050510UP; 23050521UP; 25030075UP; 22060416UC; 21120039UC; 25040164UP; 25040176UP; 25040180UP; 25040163UP; 25040165UP; 25040162UP; 25040017DP; 23050090DP; 23050089DP; 23050219DP; 25040181UP; 25040170UP; 23080042UP; 25040062DP; 23080032UP; 25030120UP; 23040071DP; 23040548DP; 23070119UP; 23050543UP; 23050606UP; 23050456UP; 23050607UP; 23070148UP; 23080095UP; 23080043UP; 24030115UP; 24030147UP; 25030078UP; 23070010UP; 22070081UC; 2070006UC; 22080069UC; 22080078UC; 22080211DC; 23070158UP; 23020089UP; 25040192UP; 25040022DP; 25040046DP; 25040048DP; 25040058DP; 25040093DP; 25040063DP; 25040020DP; 25030010DP; 25040069DP; 21120010DC; 22070723UC.

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; Baxterhealthcare AS..

¿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
    The absence of incomplete tests or tests can potentially lead to sub or over infusion of critical drugs, interruption or delay of critical therapies, burn or electric shock. Baxter has not received any adverse events related to the equipment involved in this issue. Baxter asks customers to perform the following actions: 1. Colleague Infusion Pumps not impacted by this action may continue to be used safely, according to the instructions provided in the Colleague Infusion Pump User Manual. 2. Locate and identify the affected infusion pumps at your facility, according to the related list of serial numbers affected by this action, described in Appendix 1. 3. Segregate and make these equipment available to the Baxter representative to visit your facility . The representative will regularize the documentation of the equipment, anticipating its preventive maintenance and necessary tests. 4. Fill out the enclosed customer form and return it to Baxter via e-mail at or via fax to 11 5635-0106 or 0800 012 5522. Prompt return of the customer response form will prevent you from receiving this warning several times. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System; you must register and select the Health Professional option; if you are a liberal professional or Institution / Entity option; if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Baxter brazil has internally identified that some 62 test equipment documentation has been lost on time. correction is required to complete and document final release tests. therefore, the preventive maintenance of these equipments will be anticipated.
  • Acción
    Field Action Code FA-2018-008 triggered under the responsibility of the company Baxter Hospitalar. Will make field correction