Events

Alerta De Seguridad para HeartWare HVAD Pump Implant Kit

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por HeartWare.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-02-19
  • Fecha de publicación del evento
    2013-02-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130219.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: heartware hvad pump implant kit the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning heartware hvad pump implant kit. below please see the details of the affected devices: product code: 1100, 1102, 1104, 1205 serial no.: hw001‐hw3827 and hw10000‐hw10675 according to heartware, an investigation of customer complaints has confirmed a small number of events (11 of approximately 2900 implants) where the rear portion of the hvad pump’s driveline connector housing becomes partially separated or fully separated from the front portion of the driveline connector. in the unlikely event of a separation, a repair may be necessary. if left unattended, electrical connection to the controller could be affected and a stop alarm could result. heartware reported that none of the 11 confirmed events resulted in harm to the patients affected. heartware is implementing manufacturing process changes to prevent recurrence of this event. meanwhile, users are advised to inspect the patient’s driveline connector at each routine clinic visit. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con234577 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2013.

Device

HeartWare HVAD Pump Implant Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: HeartWare HVAD Pump Implant Kit
  • Manufacturer
    HeartWare

Manufacturer

HeartWare
  • 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
    DH