Events

Retiro De Equipo (Recall) de Baxter Irrigation solutions

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00329-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00329-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    An investigation into an adverse event report concerning a 6l renal dialysis solution that affected a single patient revealed the solution had been diluted. baxter healthcare is recalling the irrigation solutions listed above as further investigations revealed that these products were also potentially diluted with water for injection.
  • Acción
    Customers are advised to locate and remove affected product from potential use. The TGA has published a web statement regarding this recall which is available at https://www.tga.gov.au/alert/dianeal-peritoneal-dialysis-solution-and-various-irrigation-solutions

Device

Baxter Irrigation solutions
  • Modelo / Serial
    Baxter Irrigation solutions1.5% Glycine IrrigationCode: AHB7316Batch: S63S1Expiry: 30/09/20150.9% Sodium Chloride for Irrigation Code: AHB7616Batch: S66P2Expiry: 30/11/2015 0.9% Sodium Chloride for IrrigationCode: AHB7616Batch: S71N8Expiry: 31/03/20161.5% Glycine Irrigation SolutionCode: AHB7317Batch: S74P6Expiry: 31/05/20160.9% Sodium Chloride for Irrigation Code: AHB7127Batch: S82F6Expiry: 31/10/2016ARTG number: 155928
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd