Events

Retiro De Equipo (Recall) de BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic 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-00025-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-08
  • 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-00025-2
  • 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 diagnostics has observed that in very rare cases false short clotting times for pt on bcs and bcs xp with dade innovin can occur. these false short clotting times were observed with turbid, haemolytic and/or icteric samples from intensive care patients. the corresponding reaction curves of these rare samples showed a pre-peak, which can lead to falsely short clotting time. in rare cases the result was not flagged by the existing check algorithms.There is a potential to miss a prolonged prothrombin time which could lead to a delay of intervention and a risk of a significant bleed.
  • Acción
    Siemens is advising users check the inference levels given in the respective Application Sheets of the BCS and BCS XP systems, as such an effect can occur in turbid, haemolytic or icteric samples from intensive care patients. Siemens will provide a software upgrade which can identify irregular reaction curves in the near future. This action has been closed-out on 27/01/2017.

Device

BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic devic...
  • Modelo / Serial
    BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic device (IVD)BCSSiemens Material Number (SMN):10454728, 10454729, 10454742, 10459303,10460659, 10461881 BCS XPSMN: 10459330, 10462449, 10461894, 10470625 Dade InnovinSMN: 10284500, 10445704, 10445705, 10445706, 10465673, 10465674ARTG Numbers: 178116 & 178501
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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