Events

Retiro De Equipo (Recall) de Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet Australia 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-00365-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-27
  • 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-00365-1
  • 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
    The fan assembly for specific system 98/98xt, cs100/cs100i and cs300 iabps could potentially contain a misshapen retaining ring. this retaining ring could disengage within the fan assembly, causing the fan to stop rotating, which causes the power supply to overheat and the iabp to shut down without any visual or audible warning. patients receiving iabp therapy are in critical condition and a sudden interruption of therapy could result in unsafe haemodynamic instability.
  • Acción
    Clinicians are instructed to not leave the patient unattended during IABP therapy. Maquet is reminding users of the current warning in the IABP operating instructions ie, the patient balloon should not remain inactive in the patient (i.e., no inflating or deflating) for more than 30 minutes, due to the potential for thrombus formation. In the unlikely event that this situation was to occur, transfer the patient to an alternative Datascope IABP. If an alternative Datascope IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate. A Maquet Service Representative will contact hospitals to schedule the replacement of the fan assembly.

Device

Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP)

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA