Events

Retiro De Equipo (Recall) de RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/L

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 Ltd Diagnostics Division.

¿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-2013-RN-01310-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-20
  • 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-2013-RN-01310-1
  • 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 advising of an issue with rapidlyte arterial blood syringes when used with radiometer brand blood gas analysers. the plunger tip in the rapidlyte 3ml arterial draw line does not remain stationary when the probe of the analyser extends into the syringe. this can result in difficulties aspirating the sample or the plunger may get pushed out of the syringe.
  • Acción
    Siemens is advising their customers to cease using RAPIDLyte syringes on Radiometer Blood Gas systems. The syringes can continue to be used on any Siemens Blood Gas Analysers.

Device

RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/L
  • Modelo / Serial
    RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/LReference number: 04180028Siemens Part Number: 103202963 mL Line Draw, 21 IU, Aspirating, L/LReference number: 06194484Siemens Part Number: 103239253 mL Line Draw, 70 IU, Aspirating, L/LReference number: 06380806Siemens Part Number: 104909663 mL Line Draw, 70 IU, Aspirating, L/SReference number: 00355281Siemens Part Number: 10313293Multiple lot numbers affected
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA