Events

Retiro De Equipo (Recall) de Smiths CADD-Solis Ambulatory Infusion Pumps

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
    18586
  • Fecha de inicio del evento
    2015-05-27
  • 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
    Smiths medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some cadd-solis pumps. binding of the cassette/ keypad lock can occur after latching the cadd-solis medication cassette reservoir or administration set "disposable" to the pump. when binding occurs, it can prevent the key from fully rotating the cassette/ keypad lock to the locked (engaged) position. if the user is unable to fully engage the cassette/ keypad lock the keypad will be locked and the pump cannot be started in pca mode.
  • Acción
    Product to be modified

Device

Smiths CADD-Solis Ambulatory Infusion Pumps
  • Modelo / Serial
    Model: Model Numbers: 2111 (grey keypad), 2112 (yellow keypad), 2120 (VIP), Affected: Serial Number 1061043 through 1067598
  • Manufacturer
    Smiths Medical MD Inc

Manufacturer

Smiths Medical MD Inc