Events

Alerta De Seguridad para HeartWare HVAD System Controller/ Controller Kits

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
    2018-08-31
  • Fecha de publicación del evento
    2018-08-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180831.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: medtronic heartware hvad system controller/ controller kits medical device manufacturer, heartware (a part of medtronic), has issued a medical device safety alert concerning its heartware hvad system controller/ controller kits [model numbers: 1403, 1407, 1420; serial number range: con300175 – con320540]. the manufacturer has become aware that the controller units in the range mentioned above may not meet the labeled standard for protection against water or fluid ingress. some units have the potential to develop hairline cracks at the power ports of the controller housing. the cracks may allow for water or fluid ingress if the patient does not follow the instructions for use and the patient manual, including use of a water-resistant shower bag to help protect the unit. this can lead to varying degrees of controller malfunction, including pump stop. according to the manufacturer, the cracks were found during manufacturer inspection of product under 10 x magnifications and are not visible without magnification. the root cause was determined to be a latent interaction between the materials used in the housing unit and the nitrile rubber gasket of the power port connector. the manufacturer recommends the following patient manual instructions should be reinforced: patients currently supported by the hvad system should follow all instructions in their patient manuals regarding water or fluid avoidance, which remain unchanged, and understand the importance of always using a shower bag when showering. if a patient encounters a situation in which their hvad system controller is exposed to water or fluid outside of conditions described in the ifu and patient manual, the patient should be advised to contact his/her vad coordinator. if further assistance is needed, clinicians should contact their local supplier. the manufacturer and the independent practitioner quality panel do not recommend proactive controller exchanges as a result of this potential issue. the manufacturer has since resolved this issue in the manufacturing process, and all newly distributed controller units are no longer susceptible to this materials interaction. no other hvad system components are susceptible to the issue. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 august 2018.

Device

HeartWare HVAD System Controller/ Controller Kits
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic HeartWare HVAD System Controller/ Controller Kits
  • 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