Events

Alerta De Seguridad para Heater Cooler Device

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

¿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
    2014-08-07
  • Fecha de publicación del evento
    2014-08-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140807b.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: sorin heater cooler device medical device manufacturer, sorin, has issued a field safety notice (fsn) concerning its heater cooler device. during the investigation work on some cardiac surgery patients infected with a slow growing mycobacterium chimaera, it has been identified that some hospitals’ heater cooler devices are contaminated. the manufacturer advises users that they can continue to safely use the heater cooler devices in accordance with the operator’s manual. it also recommends users of the followings: review information in fsn to assure that users are aware of proper water management in cardiac surgery theatre. specifically, assure that users understand mycobacteria and the potential contamination risks for cardiac surgeries as mentioned in the fsn. review heater cooler operating practices and cardiac surgery theatre water management practices. also evaluate heater cooler device(s) for potential contamination. refer to the heater cooler device operator’s manual and/or information in fsn, and review the necessary disinfection practices to assure practices are aligned with the directions. if users are concerned that vigilance to the operating instructions may be in question, perform microbiological sampling of the water in heater cooler device, disinfect the device and determine if decontamination is necessary. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 7 aug 2014.

Device

Heater Cooler Device
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Sorin Heater Cooler Device
  • Manufacturer
    Sorin

Manufacturer

Sorin