Events

Retiro De Equipo (Recall) de RAPIDPoint 500 Blood Gas Analyzer

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2015-RN-00700-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-31
  • 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-2015-RN-00700-1
  • 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
    Siemens is informing customers of potential issue when both ports (serial and ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port. this could cause the message received by the lis (data management system) to include either: duplicate data, missing data and data from a different patient. the risk to health is limited to the extremely unlikely situation in which an analyte is switched between two patients. a transposed sodium, potassium, glucose, lactate, carboxyhemoglobin, methemoglobin, or neonatal bilirubin result may lead to a potential risk to health when the true value is critical.In all cases, the probability of occurrence is extremely unlikely due to the low frequency of the software issue and correlation with patient clinical presentation, history, and concurrent laboratory testing.
  • Acción
    Siemens is providing end users with instructions on how to disable Dual Port LIS transfer. The resolution of this issue will be addressed in the next software update. This action has been closed-out on 01/03/2018.

Device

RAPIDPoint 500 Blood Gas Analyzer

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA