Retiro De Equipo (Recall) de BodyGuard Pump IV Administration Set

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por REM Systems 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-00446-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-10
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    The manufacturer caesarea medical electronics (cme) has identified that the sr segment in the sets from two batches have slight variations in dimensions, in some places being at borderline specification. these random variations along the tubing, when used in intermittent mode that includes long intervals of zero or near zero rate, may yield under- infusion results.
  • Acción
    REM Systems is advising users to review their stock and quarantine the affected batches. Replacement stock will be provided by REM Systems.

Device

  • Modelo / Serial
    BodyGuard Pump IV Administration SetCatalogue Number: CE-GEN00014Batch Numbers: 12387350 & 1483529ARTG Number: 119624
  • Manufacturer

Manufacturer