Events

Alerta De Seguridad para HeartWare Ventricular Assist System

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
    2015-06-17
  • Fecha de publicación del evento
    2015-06-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150617.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 ventricular assist system the united states food and drug administration (fda) has issued medical device safety alerts concerning heartware ventricular assist system (vas), manufactured by heartware. the affected devices are identified as follow:- product codes: 1101, 1103 serial numbers: all heartware systems currently in use manufacturing and distribution dates: january 2008 to march 2015 the alignment guides in the power supply connector ports may wear down over time. this can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their vas. an interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. the company has reported 33 reports of malfunction and one serious injury related to this problem. the manufacturer sent their customers an urgent medical device correction notice on may 25, 2015 to alert them of the problem and actions to take. the manufacturer will replace all defective controllers by the end of june 2016. the manufacturer is reminding patients to use the device safely: never disconnect from both power sources at the same time. take care when connecting to power sources. keep the outer sheath of the driveline protected from excessive sunlight. beware of accidental snagging or pulling of the driveline. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm451456.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm451447.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 june 2015.

Device

HeartWare Ventricular Assist System
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Medical Device Safety Alert: HeartWare Ventricular Assist System
  • 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