Events

Retiro De Equipo (Recall) de Radiometer ABL800 blood gas analysers with software versions 6.14 through to Version 6.18. An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific Pty Ltd.

¿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
    RC-2018-RN-00926-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-09
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00926-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Radiometer has recently become aware that the abl800 series analysers could potentially induce a patient mix-up when “confirmation of demographics” is enabled as part of the query to aqure, radiance, or a his lis system. please note that the default setting for this function is ‘disabled’.The described error may potentially impact upon patient management as the physician may subject the patient to unnecessary treatment or erroneously withhold necessary treatment from the patient based upon the mixed-up of patient identification. in a worst-case scenario, where a critical parameter, such as k+ or po2, is interrogated, based upon a false clinical diagnosis inferred from the erroneous measurement, a critically ill patient may be subjected to lack of critical treatment.
  • Acción
    Radiometer is advising that they are currently working on revising the software to correct this issue. Once release, a Radiometer representative will contact users to schedule a visit for the software upgrade. In the interim, users are requested to confirm if "Confirmation of Demographics" is disabled on their analysers. If disabled, the issue will not be experienced. If enabled, one of the two following counter-measures (CM) must be implemented: CM #1: Disable “Confirmation of Demographics” as follows: a. Logon to the analyzer. b. Select “Menu” > “Utilities” > “Setup” > “General Setup” > “Communications” > “Automatic Data Request” c. Remove the checkmark for “Confirm requested data”, if present. d. Select “Close”. Or CM #2: If disabling the “Confirmation of Demographics” (CM #1) is not possible due to e.g. internal procedures, instruct all operators of the analyser(s) to not introduce a new sample when the menu for “Confirmation of Demographics” is being displayed.

Device

Radiometer ABL800 blood gas analysers with software versions 6.14 through to Version 6.18. An in ...
  • Modelo / Serial
    Radiometer ABL800 blood gas analysers with software versions 6.14 through to Version 6.18. An in vitro diagnostic medical device (IVD). ARTG Number: 228382(Radiometer Pacific Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd