Events

Retiro De Equipo (Recall) de ADVANCED PERFUSION SYSTEM 1 - BASE UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por RYAN MEDICAL DISTRIBUTORS INC..

¿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
    55469
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-11-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Terumo cvs initially received nine reports of malfunction of the abd module or the occluder module for the terumo advanced perfusion system 1. its investigation found a faulty component on the modules application board had caused the failures. terumo cvs replaced all modules in the affected population. terumo cvs has subsequently received two additional reports of similar malfunctions. the ensuing investigation concluded that though highly unlikely it is possible for the same component to fail in any module.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Modelo / Serial
    Model Catalog: 801763 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    Terumo Advanced Perfusion System 1 - Base Unit
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.