Events

Retiro De Equipo (Recall) de S5 HEART LUNG MACHINE - MAST MOUNTED ROLLER PUMPS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LIVANOVA CANADA 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
    48497
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-11
  • 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
    Sorin has become aware of an increased trend in reports of "fault in motor controller (433)" alarm message events with certain mast roller pumps (mrp) 85 (product code 10-88-60) manufactured between october 6 2011 and august 20 2013. the failure occurs following an intended pump stop. the mrp stops and provides a visual and audible alarm on the system panel. the alarm can be cleared by pressing the reset button and the pump restarted by turning the setting knob. all complaints are related to specific hme motor control circuit boards (product code 90-305-700).

Device

S5 HEART LUNG MACHINE - MAST MOUNTED ROLLER PUMPS
  • Modelo / Serial
    Model Catalog: 50-80-62 (Lot serial: HME LOT 12070074); Model Catalog: 50-80-62 (Lot serial: 50E50974); Model Catalog: 50-80-62 (Lot serial: 50E50973); Model Catalog: 50-80-62 (Lot serial: 50E50970); Model Catalog: 50-80-62 (Lot serial: 50E50969); Model Catalog: 50-80-62 (Lot serial: 50E50783); Model Catalog: 50-80-62 (Lot serial: 50E50799); Model Catalog: 50-80-62 (Lot serial: 50E50798); Model Catalog: 50-80-62 (Lot serial: 50E50797); Model Catalog: 50-80-62 (Lot serial: 50E50784); Model Catalog: 50-80-62 (Lot serial: 50E50800)
  • Descripción del producto
    S5 MAST MOUNTED ROLLER PUMPS (MRP) 85
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    HC