Events

Alerta De Seguridad para HeartWare Ventricular Assist System Pump Driveline Splice 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
    2015-05-21
  • Fecha de publicación del evento
    2015-05-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150521.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 pump driveline splice kit the united states food and drug administration (fda) has issued a medical device safety alert concerning heartware ventricular assist system (hvad) pump driveline splice kit. the affected devices are identified as follow:- model: 1) hvad pump driveline splice kit; 2) hvad pump driveline splicekit; large od sheath catalogue numbers: 1) asy00116; 2) asy00281 lot numbers: 1) 532770, 567949, 480786, 483769, 490692, 539664, 598189; 2) 654090, 672401, 678800, 690423, 833963, 873159, 880816 according to the manufacturer, excessive force applied will cause failures of the splice repair kit. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1604-2015&w=05202015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 may 2015.

Device

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