Events

Retiro De Equipo (Recall) de Alaris System PC Unit (PCU) model 8015, software version 9.12

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-2013-RN-00707-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-12
  • 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-2013-RN-00707-1
  • 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
    In the affected devices, the keyboard processor is operating at an incorrect voltage. the correct voltage should be at 1.8 volts however the affected units are at 1.4 volts. due to this issue the alaris system pcu software v9.12 while in operation could potentially experience a loss of communication between the pcu main processor and keyboard processor. the alaris system pcu will display either a system error (error codes 111.2000 or 111.2002) or channel disconnected error message. along with the pcu display the alaris system pcu also produces an audible alarm and the attached modules will display a scrolling "communication error" message. during the communication error, the pump will alarm both visually and audibly.
  • Acción
    Customers are asked to weigh the risk/benefit to patients before continuing to use the affected PCU, version 9.12. Either discontinue use of affected PC units until remediated or continue use on patients by implementing work around instruction identified in the customer letter. CareFusion Technical Service will provide a software update to correct the voltage on the keyboard processor for those affected Alaris System PC units.

Device

Alaris System PC Unit (PCU) model 8015, software version 9.12
  • Modelo / Serial
    Alaris System PC Unit (PCU) model 8015, software version 9.12Multiple serial numbers affectedARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd