Events

Retiro De Equipo (Recall) de Radiometer ABL90 Series Blood Gas Analysers

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
    21043
  • Fecha de inicio del evento
    2017-01-24
  • 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
    On the abl90 series analyzers the sample type cord blood has been changed into the two sample types cord blood arterial and cord blood venous. this change took place with software version 3.1 mr5. the selected sample type is displayed correctly on the abl90 series analyzer itself. irrespective of the sample type selected on the abl90 series analyzer during sample processing, the analyzer will transmit the less specific sample type cord blood to a his/lis or middleware system., an operator who is aware that the sample types that can be selected on the abl90 series analyzer are cord blood arterial and cord blood venous may notice that a less specific sample type cord blood appears in the his/lis or middleware system., error may in a worst-case scenario lead to minor fetal hypoxic stress not being immediately recognized if the clinician was to use data from the his/lis or middleware system to determine treatment., this may cause a delay of treatment for newvborn infant.
  • Acción
    Software to be upgraded

Device

Radiometer ABL90 Series Blood Gas Analysers

Manufacturer

Radiometer Medical ApS