Events

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

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TERUMO CARDIOVASCULAR SYSTEMS CORP..

¿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
    153878
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-08-10
  • 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 ten reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities using the following modules for the terumo advanced perfusion system 1: serial interface module rs-232 serial interface module rs-485 interface module for cdi system 100/101 interface module for cdi system 500. some reports stated that the odor of smoke was associated with the failures. the malfunctions occurred during set-up during cardiopulmonary bypass and during routine testing of the module. terumo cvs' investigation has determined that the malfunctions are caused by a circuit board that failed.

Device

ADVANCED PERFUSION SYSTEM 1 - MODULES
  • Modelo / Serial
    Model Catalog: 803479 (Lot serial: 00366-00498 (802113)); Model Catalog: 802113 (Lot serial: 00366-00498 (802113)); Model Catalog: 803518 (Lot serial: 00216-00283 (802113)); Model Catalog: 803479 (Lot serial: 00216-00283 (802113)); Model Catalog: 802113 (Lot serial: 00216-00283 (802113)); Model Catalog: 803518 (Lot serial: 00123-00214 (802113)); Model Catalog: 803479 (Lot serial: 00123-00214 (802113)); Model Catalog: 802113 (Lot serial: 00123-00214 (802113)); Model Catalog: 803518 (Lot serial: 00080-00121 (802113)); Model Catalog: 803479 (Lot serial: 00080-00121 (802113)); Model Catalog: 802113 (Lot serial: 00080-00121 (802113)); Model Catalog: 803518 (Lot serial: 00066-00077 (802113)); Model Catalog: 803479 (Lot serial: 00066-00077 (802113)); Model Catalog: 802113 (Lot serial: 00066-00077 (802113)); Model Catalog: 803518 (Lot serial: 00047-00064 (802113)); Model Catalog: 803479 (Lot serial: 00047-00064 (802113)); Model Catalog: 802113 (Lot serial: 00047-00064 (802113)); Model Catalog: 803518 (Lot serial: 00
  • Descripción del producto
    SERIAL INTERFACE MODULE RS-232 INTERFACE MODULE FOR CDI SYSTEM 500 SERIAL INTERFACE MODULE RS-485
  • Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS CORP.
  • Dirección del fabricante
    ANN ARBOR
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    HC