Events

Retiro De Equipo (Recall) de HeartWare Ventricular Assist System batteries

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Heartware Pty Ltd.

¿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
    RC-2014-RN-00902-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-14
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00902-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    In may 2014, heartware distributed recall for product correction letter (tga ref: rc-2014-rn-00510-1/ heartware ref: fsca apr2014.1) following an increase in reported power management complaints related to earlier than expected battery depletion. information on early battery depletion, identification of potentially faulty batteries, and recommended practices for power management were provided in the recall for product correction letter.Heartware is expanding the action to include the recall of batteries produced within the serial number ranges: bat000001 to bat039999 and bat090000 to bat099999. batteries produced in these ranges are more likely to exhibit premature or unrecognized deterioration of battery capacity, which poses a risk to the patient since it may result in a pump stop.
  • Acción
    HeartWare is requesting their clinicians to review their hospital’s current inventory and remove and quarantine any affected batteries. At each patient’s next regularly scheduled visit, inspect their batteries and replace affected batteries with batteries having serial numbers BAT040000 to BAT089999 or BAT100000 and above. If a patient does not have a regular visit scheduled within the next 90 days, contact that patient by telephone to check the serial numbers of the patient’s batteries. This action has been closed-out on 13/10/2016.

Device

HeartWare Ventricular Assist System batteries
  • Modelo / Serial
    HeartWare Ventricular Assist System batteriesProduct code: 1650Serial number range for the affected batteries: BAT000001 to BAT039999; BAT090000 to BAT099999ARTG number:181875
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Ltd

Manufacturer

Heartware Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA