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
    137887
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-09-14
  • 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 multiple reports of false alarms generated by the air bubble detection system used with the terumo advanced perfusion system 1 the sarns modular perfusion system 8000 and the sarns perfusion system 9000. terumo cvs' investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. therefore terumo cvs has concluded that it is necessary to amend the operator's manuals for its heart-lung machines to: - alert all users of the potential for a malfunction of the air bubble detection system - reinforce the mitigation procedures in the event of a malfunction.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Modelo / Serial
    Model Catalog: 801763 (Lot serial: 1361); Model Catalog: 801763 (Lot serial: 0017); Model Catalog: 801763 (Lot serial: 0020); Model Catalog: 801763 (Lot serial: 0021); Model Catalog: 801763 (Lot serial: 1412); Model Catalog: 801763 (Lot serial: 1411); Model Catalog: 801763 (Lot serial: 1374); Model Catalog: 801763 (Lot serial: 1367); Model Catalog: 801763 (Lot serial: 0013); Model Catalog: 801763 (Lot serial: 1360); Model Catalog: 801763 (Lot serial: 1340); Model Catalog: 801763 (Lot serial: 1312); Model Catalog: 801763 (Lot serial: 1177); Model Catalog: 801763 (Lot serial: 0396); Model Catalog: 801763 (Lot serial: 0193); Model Catalog: 801763 (Lot serial: 0170); Model Catalog: 801763 (Lot serial: 0146); Model Catalog: 801763 (Lot serial: 0144); Model Catalog: 801763 (Lot serial: 0142)
  • Descripción del producto
    TERUMO ADVANCED PERFUSION SYSTEM 1: OPERATOR'S MANUAL ULTRASONIC AIR SENSOR
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.