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
    85356
  • 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 advanced perfusion system 1 battery charge is being depleted faster than expected during periods of system shutdown. the system 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use such as would occur with a backup system. this may result in unexpected system shutdown. prolonged battery depletion may cause permanent battery damage.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Modelo / Serial
    Model Catalog: 801763 (Lot serial: 1109-1445); Model Catalog: 801763 (Lot serial: 1412); Model Catalog: 801763 (Lot serial: 1100); Model Catalog: 801763 (Lot serial: 1037-1049); Model Catalog: 801763 (Lot serial: 1001-1034); Model Catalog: 801763 (Lot serial: 0337-0610); Model Catalog: 801763 (Lot serial: 0011-0335); Model Catalog: 801763 (Lot serial: 1447-1450); Model Catalog: 801763 (Lot serial: 0013); Model Catalog: 801763 (Lot serial: 0017); Model Catalog: 801763 (Lot serial: 0020); Model Catalog: 801763 (Lot serial: 0021); Model Catalog: 801763 (Lot serial: 0142); Model Catalog: 801763 (Lot serial: 0144); Model Catalog: 801763 (Lot serial: 0146); Model Catalog: 801763 (Lot serial: 0170); Model Catalog: 801763 (Lot serial: 0193); Model Catalog: 801763 (Lot serial: 0396); Model Catalog: 801763 (Lot serial: 1177); Model Catalog: 801763 (Lot serial: 1312); Model Catalog: 801763 (Lot serial: 1340); Model Catalog: 801763 (Lot serial: 1360); Model Catalog: 801763 (Lot serial: 1361); Model Catalog: 801763 (Lot
  • Descripción del producto
    TERUMO ADVANCED PERFUSION SYSTEM 1 - BASE UNIT (100/120V)
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.