Events

Retiro De Equipo (Recall) de ANIMAS 2020 INSULIN INFUSION PUMP (VARIOUS COLOURS)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON 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
    28018
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2010-03-23
  • 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
    Animas 2020 and onetouch ping insulin pumps that have sustained external impact may have damaged the force sensor which can cause the whole cartridge of insulin to be dispensed during the "load cartridge" step of the priming sequence. failure to follow safety instructions and disconnect the infusion set from the body during the "rewind load and prime" steps can lead to unintended delivery of insulin.

Device

ANIMAS 2020 INSULIN INFUSION PUMP (VARIOUS COLOURS)
  • Modelo / Serial
    Model Catalog: 200-260-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-385-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-262-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-263-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-264-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-265-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-371-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-370-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-372-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-374-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 200-375-00 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-380-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-381-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-382-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 100-384-51 (Lot serial: > 1000 NUMBERS CONTACT MFG); Mod
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    Animas 2020 Insulin Pump
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    BURNABY
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC