Events

Retiro De Equipo (Recall) de Smiths Medical CADD administration Set with flow stop

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 Smiths Medical MD Inc.

¿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
    20164
  • Fecha de inicio del evento
    2016-05-18
  • 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: Smiths Medical Australasia Pty Ltd, c/o KPMG, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland
  • Causa
    It has become aware that under delivery to patients of medicinal products may occur when administered using cadd® administration sets with flow stop. test data indicates that under infusion has the potential to contribute to an average of an additional 5.2% under delivery beyond the +/- 6% stated in the operator's manual for the cadd® pumps.
  • Acción
    Product to be destroyed

Device

Smiths Medical CADD administration Set with flow stop

Manufacturer

Smiths Medical MD Inc