Events

Alerta De Seguridad para Haemodialysis bloodline for 4008 dialysis machine

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

¿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
    2015-04-15
  • Fecha de publicación del evento
    2015-04-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150415c.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: fresenius medical care haemodialysis bloodline for 4008 dialysis machine medical device manufacturer, fresenius medical care, has issued a medical device safety alert concerning haemodialysis bloodline for 4008 dialysis machine [article numbers: i) ap16661 av-set b dt inf-e; ii) ap16843 av-set dt-e. batch numbers: i) vhc231, vhc231a, vic252, vkc262, vlc202, vmc261; ii) vhc012, vic011, vic033, vic192, vic251, vic263, vic291, vkc042, vkc071, vkc094, vkc301, vlc032, vmc041, vmc172, vmc193, wac114, wac143, wac163, wac191, wac221, wac312]. the manufacturer has observed an increased likelihood of blood leakage between dialyzer connector and tubing during post marketing surveillance. it has been determined that a supplied material used in the dialyzer connector manufactured between august 2014 and march 2015 is causing a weak seal between the connector and tubing. the manufacturer has corrected this issue with an alternate approved and validated connector material. users are advised to stop using the affected products immediately. product recall is ongoing. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 april 2015.

Device

Haemodialysis bloodline for 4008 dialysis machine
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Fresenius Medical Care Haemodialysis bloodline for 4008 dialysis machine
  • Manufacturer
    Fresenius Medical Care

Manufacturer

Fresenius Medical Care