Events

Retiro De Equipo (Recall) de Colleague Volumetric Infusion Pumps

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-2014-RN-00384-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-31
  • 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-2014-RN-00384-1
  • 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
    During 2011, it was identified that a quantity of pumps fitted with two ceramic 1.6a slow-blow fuses in the rear housing was failing prematurely. investigation led to a change of the fuse type fitted during future manufacture and service, from a ceramic fuse to a glass fuse, which has a different rupture characteristic. the failure rate of this reported issue has subsequently declined following the replacement with a glass fuse in newly manufactured pumps. if the fuses fail the device cannot charge the batteries even when connected to a.C. power. failure of the fuses while the pump is in operation would result in the pump switching from a.C. power to battery power and the a.C. icon would extinguish. the pump would continue to run on battery power with corresponding battery discharge alarms.
  • Acción
    Customers are asked to examine the two fuses installed in the rear of the pump which can be accessed by slotted fuse covers to establish if the fuses are glass or ceramic type. Ceramic fuses should be replaced with the glass fuses which will be supplied by Baxter. For Baxter owned pumps placed with customers, Baxter will carry out this activity at the next service.

Device

Colleague Volumetric Infusion Pumps
  • Modelo / Serial
    Colleague Volumetric Infusion Pumps Product Codes: 2M91617 & 2M91637 ARTG Number: 177494
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd