Events

Retiro De Equipo (Recall) de MERLIN PATIENT CARE SYSTEM - PROGRAMMER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ABBOTT MEDICAL CANADA 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
    143412
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-10-11
  • 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
    A new management tool has been developed for clinicians to monitor patients who have devices subject to the october 2016 lithium cluster advisory to provide earlier notification of abnormal battery performance that may lead to premature battery depletion due to lithium cluster induced shorts. this tool will provide notification to clinicians via merlin.Net and upon interrogation with the merlin programmer to help identify voltage drops indicative of lithium clusters. the tool will be rolled out as a two part upgrade. the first upgrade is to merlin.Net (not a medical device) followed by merlin patient care system (pcs) programmer when the applicable software testing has been completed. refer to prior medical device advisory october 2016 for corrective measures implemented in association with the original advisory. in addition if a bpa alert is detected explant of the device is required.

Device

MERLIN PATIENT CARE SYSTEM - PROGRAMMER
  • Modelo / Serial
    Model Catalog: 3650 (Lot serial: N/A)
  • Descripción del producto
    MERLIN PATIENT CARE SYSTEM-PROGRAMMER
  • Manufacturer
    ABBOTT MEDICAL CANADA INC.

Manufacturer

ABBOTT MEDICAL CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC