Events

Retiro De Equipo (Recall) de RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). 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 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-2016-RN-01187-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-09
  • 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-2016-RN-01187-1
  • 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 has confirmed an error in the value assignment for the chloride calibrators in the rapidpoint 400 and rapidpoint 405 measurement cartridge for certain cartridge serial numbers. the maximum % bias observed due to error ranges from -2.3% at 65mmol/l to +5.9% at 132 mmol/l. at extremely high chloride values (>122 mmol/l), a positive bias of 5% or greater may be observed. there have not been any reports of injury due to this issue. all the other electrolytes (na+, k+, ca++) and blood gas parameters are correctly assigned in these measurement cartridges.
  • Acción
    Siemens is advising users to review the chloride calibrators bias information provided in the recall for product correction letter with their Medical Director.

Device

RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic me...
  • Modelo / Serial
    RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic medical device (IVD).RAPIDPoint 400 Measurement Cartridge Siemens Material Numbers (SMN): 10329756, 10341161RAPIDPoint 405 Measurement CartridgeSiemens Material Numbers (SMN): 10844812, 10283222, 10313971, 10310469Cartridge Serial Numbers: 2610900214 through 2621001325ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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