Events

Retiro De Equipo (Recall) de HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery

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-2015-RN-01261-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-01-07
  • 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-2015-RN-01261-1
  • 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
    Heartware ac adapters with serial numbers cac000001 to cac005796 are vulnerable to power grid surges above 220 volts. if an ac adapter fails, the patient’s controller will alarm and automatically switch to the other power source. if patients follow heartware’s patient manual, there are no elevated risks to health. however, if a patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a failed ac adapter, the system could lose power, which may lead to serious injury or death.In addition, there have been complaints related to earlier than expected battery depletion for batteries with serial numbers bat000001 to bat199999. premature or unrecognised battery depletion may pose a risk to the patient, if the patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a depleted battery.
  • Acción
    The sponsor is advising healthcare professionals to identify and quarantine the affected units in hospital inventory and arrange for current patients to bring their AC Adapters and Batteries to a clinic as soon as possible (at least within the next three months), with urgency dependent upon individual patient circumstances. During their scheduled appointment, a qualified representative will assist with the quarantine and replacement of the affected product. For further information, please see http://www.tga.gov.au/alert/heartware-ventricular-assist-device-ac-adapters-and-batteries .

Device

HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery
  • Modelo / Serial
    HeartWare HVAD Controller AC Adapter and HeartWare HVAD BatteryController AC Adapter Product Code: 1430XXSerial Numbers: CAC000001 to CAC005796 HVAD BatteryProduct Code: 1650XX and A00035 Serial Numbers: BAT000001 to BAT199999ARTG Number: 181875
  • 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