Events

Retiro De Equipo (Recall) de Gambro AK200s and AK200 Ultra S Haemodialysis Monitors

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Gambro Lundia AB.

¿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
    18055
  • Fecha de inicio del evento
    2015-02-10
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Gambro Pty Ltd (NZ), 5B Target Court, Glenfield, Auckland 0753
  • Causa
    Gambro has received some complaints related to a technical error which will stop all the pumps and close the venous clamp. one section in the operator's manuals for the ak 200 s and the ak 200 ultra s instructs the user to contact technical service and to restart the blood pump to return the extracorporeal blood to the patient. restarting the blood pump is however not possible, since the venous clamp is closed and the consequence will be a blood loss for the patient.
  • Acción
    Instructions for use to be updated

Device

Gambro AK200s and AK200 Ultra S Haemodialysis Monitors

Manufacturer

Gambro Lundia AB