Events

Retiro De Equipo (Recall) de Sysmex CA-600 series with built-in barcode reader. 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-2017-RN-00807-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-22
  • 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-2017-RN-00807-1
  • 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 healthcare has been advised by sysmex corporation about a phenomenon affecting the specific sysmex ca-600 series systems. under rare circumstances there is the potential that the system might fail to alert the operator about an individual sample id number assigned to multiple patient measurement results when using the built-in barcode scanner. this may lead to an incorrect diagnostic and patient treatment decision due to potential of a mismatched result for the patient.
  • Acción
    Sysmex is advising that: 1. In case an error message "Barcode Scanner Driver Error" appears during a CA-600 series sampler run with built-in barcode scanner, a blockage has stopped the barcode scanner from normal operation. The scanner cannot move from home position to #1, #2, ..#10 (all) sample tube position at the sampler rack, then back to home position. 2. Remove any block or failure. 3. Before clearing the error, confirm on the instrument display if the same sample IDs exist on the measurement results. The number of samples loaded should match the number of sample ID# displayed, & should correspond to the barcoded sample IDs for each of the samples loaded in the rack. 4. If you find anything wrong on the measurement results for the patient sample ID, reset the sample ID according to the note described in "5.11 Set Sample Nos." section of IFU. 5. Do not report previous patient results & restart analysis, verify results & sample ID No. for all specimens in the rack.

Device

Sysmex CA-600 series with built-in barcode reader. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Sysmex CA-600 series with built-in barcode reader. An in vitro diagnostic medical device (IVD)Sysmex CA-620Siemens Material Number (SMN): 10712040Sysmex CA-660Siemens Material Number (SMN): 10712039ARTG Number: 179939
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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