Events

Alerta De Seguridad para Sarns Soft-Flow Aortic Cannulae

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

¿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
    2012-12-24
  • Fecha de publicación del evento
    2012-12-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121224.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: terumo sarns soft-flow aortic cannulae medical device manufacturer, terumo cardiovascular systems corporation, has issued a medical device safety alert concerning sarns soft-flow aortic cannulae. affected catalogue numbers are 5762, 5768, 5774, 5841, 5843, 5845, 5847, 7071, 7072. during in-house inspection, terumo cardiovascular systems (terumo cvs) identified the presence of excess plastic material, or flash, on the tip of the sarns soft-flow aortic cannula. the flash has the potential to detach. terumo cvs’ investigation revealed that: the flash occurred during the molding process of the cannula tip. other product lots may exhibit the same issue. the mold was corrected to resolve the observed condition. terumo cvs is advising users to discontinue use and return all affected cannulae in inventory. it is because the presence of plastic flash on the cannula tip may or may not be visually detected by users. if plastic flash material is present, there is the potential for it to become dislodged and deposited in the patient’s vascular system resulting in varying degrees of patient harm, depending on the size of the dislodged material, the location in which it is deposited, and the condition of the patient. potential outcomes include inflammatory response which can create clot, ischemia, or tissue death. according to the local supplier, the affected products have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 24 december 2012.

Device

Sarns Soft-Flow Aortic Cannulae

Manufacturer

Terumo Cardiovascular Systems Corporation