Alerta De Seguridad para MACHINE FOR HEMODIALYSIS SYSTEM 1000 - MODELS TINA, ALTRATOUCH AND AURORA .. Registration in Anvisa: 10068390356 .. Risk Class III.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BAXTER HEALTHCARE CORPORATION.

¿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
    878
  • Fecha
    2007-07-16
  • País del evento
  • Fuente del evento
    ANVISA
  • 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 company Baxter Hospitalar Ltda has become aware of the possibility of the Dialysate Monitors Blocks "with Transformer Fences" and the old "Noryl" UF Removal Regulators to develop cracks due to mechanical and thermal stress. Should any of these parts develop cracks during the treatment of the patient, there is a possibility of an ultrafiltration error that may result in excessive fluid withdrawal from the patient. If this results in intravascular volume depletion, the patient may experience muscle contractions associated with hypotension, chest pain or syncope. In order to minimize the risk of leakage, Baxter has created upgrade kits with new parts ("Non-Ferrule Fittings" and "Ultem" FB Regulators) and is updating this equipment with its customers. Anvisa's Technovigilance Unit is monitoring this case. #### Update (11/02/08): Baxter Hospitar Ltda informed the Anvisa's Technovigilance Unit about the finalization of the correction action.
  • Causa
    Possibility of fissure of the blocks of dialysate monitors (with transpassantes hardware) and of the regulators of uf removal (of noryl) in the equipment of hemodialysis, due to the thermal or mechanical stress.
  • Acción
    In order to minimize the risk of leakage, Baxter has created update kits with new parts ("Without Transformer Fence" Monitors and Ultem "UF Regulators") and is carrying out corrective field action to update this equipment with the your customers. If the hospital unit has hemodialysis equipment from Baxter, models SYSTEM 1000, TINA, ALTRATOUCH and AURORA, it must inform the company to replace the mentioned parts in the following cases: (1) if the equipment has Dialisate Monitor Block with Transpassing Hardware ; and (2) if the equipment has Noryl UF Removal Regulators. #### Update (11/02/08): Baxter Hospitar Ltda informed the Anvisa's Technovigilance Unit that the corrective action initiated by the company is finalized. According to the company, 731 machines for hemodialysis (from a total of 893 equipment under risk) were updated with the dialysate monitor block and 1027 machines for hemodialysis (out of a total of 1189 equipment under risk) with the UF regulator.

Manufacturer

  • Source
    ANVSANVISA