Alerta De Seguridad para Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets

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

¿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
    2011-12-23
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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
    Field safety notice: smiths medical voluntary recall for level 1® d/di-60hl normothermic iv fluid administration sets, and hotline® blood and iv fluid warming sets medical device manufacturer, smiths medical asd, inc., is conducting a product recall for the following products: a) level 1® d/di-60hl normothermic iv fluid administration sets, and b) hotline ® blood and iv fluid warming sets (product codes: l-70, l-70ni, l-80, l-270, and l-370). there was an increasing trend in reports of disconnections of the luer lock connector at the patient end of the tubing on certain sets of the above two products. based on the information provided by the manufacturer, if the luer lock connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in therapy, which could result in patient injury, or while highly unlikely, death. the manufacturer has received no reports of serious injury or death related to the problem. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the attached field safety notice (a) and field safety notice (b). if you are in possession of the affected products, please contact your supplier for further information and necessary actions.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smiths Medical Voluntary Recall for Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets
  • Manufacturer

Manufacturer