Events

Retiro De Equipo (Recall) de Prismaflex Control Units

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-2018-RN-00366-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-16
  • 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-2018-RN-00366-1
  • 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
    Baxter healthcare will be installing new firmware on all prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. the failure mode may result in a “voltage out of range” malfunction alarm, which causes the device to enter a “safe state” and become inoperable until it is serviced. this failure mode can occur at any time during treatment or outside of treatment. to date, there have been no reports of serious injury associated with this issue.
  • Acción
    Baxter advises that a service representative will be in contact with customers to schedule the firmware upgrade to rectify this issue. Until the firmware has been installed, users may continue to use the units that have not exhibited the "Voltage Out of Range" malfunction alarm.

Device

Prismaflex Control Units
  • Modelo / Serial
    Prismaflex Control Units Product Codes: 955052, 114870, 114489, 107493, 113082, 113874All serial numbers of the above product are affectedARTG Number: 142047(Baxter Healthcare - Prismaflex - Therapeutic plasma exchange system)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd