Alerta De Seguridad para 24 PVS27/XL, Perceval Sutureless Heart Valves, 4 PS25 Pericarbon More Heart Valves and 1 PS33 Pericarbon More Heart Valve

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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
    Medical device safety alert: sorin heart valves medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning 24 pvs27/xl, perceval sutureless heart valves, 4 ps25 pericarbon more heart valves and 1 ps33 pericarbon more heart valve, manufactured by sorin group. the manufacturer has identified the presence of corynebacterium spp in the pre-sterile bio-burden monitoring of tissue heart valve test samples in july 2014. according to the manufacturer, corynebacterium spp has never been identified during the pre-sterile bio-burden testing or in-process devices or in other controlled environments of the manufacturing facilities. the bacteria identification showed that the contamination is from corynebacterium (c. jeikeium, c. urealyticum, c. pseudodiphtercum) that are common microbial flora found on human skin and mucosal membranes. all the valves released have been sterilized with a validated sterilization process conforming to the specifications and passed a final sterility test. however, corynebacteria were not included in the validation study and the final sterility test is only indirect indicator of sterility. the manufacturer has decided to recall the captioned devices. if a contaminated valve is implanted, there is the potential for development of infectious endocarditis with all attendant complications including death, while treatment may require intravenous antibiotic therapy and reoperation for valve explantation or other measures as determined necessary by medical personnel. the manufacturer advises users to discontinue use and return any remaining inventory of the affected devices. if the affected product has been utilized, the cardiac surgeons or cardiologists primarily responsible for care of the affected patient should be notified immediately to ensure informed decision making regarding the need for further diagnostic evaluation and treatment. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con445980 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 august 2014.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Sorin Heart Valves
  • Manufacturer