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
    74072
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-08-19
  • 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 cardiovascular systems (terumo cvs) has received three reports of a terumo advanced perfusion system 1 displaying a pressure reading of '999.' terumo cvs has confirmed that in one of these cases the user was unable to clear the pressure alarm and restart the pump. note: the system displays '999' at pressures greater than +900mmhg. the reading can indicate a true high pressure or a malfunction of the pressure transducer or cable. the operator's manual for the terumo system 1 does not provide instruction on how to clear the '999' pressure reading.

Device

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

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.