Events

Retiro De Equipo (Recall) de Radiometer ABL90Flex analyser

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 Radiometer Medical ApS.

¿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
    17922
  • Fecha de inicio del evento
    2014-12-24
  • 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: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Causa
    Manufacturer has become aware of a potential significant clinical issue with patient results if the inlet is left open after aspiration of the patient sample for more than 30 seconds., note that if the inlet is accidentally left open after processing a patient sample the abl90 analyser sounds a warning bell, places a warning message on the screen and also initiates a voice message continuously repeating "please close the inlet"., the problem can occur after the following sequence of actions:, 1.The operator aspirates patient sample a and forgets to close the inlet, 2.The inlet is left open for more than 30 seconds before it is closed, 3.An operator aspirates patient sample b, in this case the results for patient sample b are affected by this issue.
  • Acción
    Instructions for use to be updated

Device

Radiometer ABL90Flex analyser

Manufacturer

Radiometer Medical ApS