Events

Alerta De Seguridad para CELLTRACKS AUTOPREP System

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

¿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
    2014-01-22
  • Fecha de publicación del evento
    2014-01-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140122b.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: cell search celltracks autoprep system medical device manufacturer, cell search, has issued a field safety notice concerning celltracks autoprep system (product code: 9541 and 9541r). the manufacturer has received reports of an increase in error codes related to the peristaltic pump tubing when using the celltracks autoprep system. there were also reports that the wash bowls overflowed after changing the peristaltic pump tubing following the monthly maintenance procedure. the monthly maintenance kit with part number ct9554 contains packages of peristaltic pump tubing and fluid bottle filters. peristaltic pump tubing may be ordered separately using the peristaltic pump tubing kit with part number ct4274. according to the manufacturer, monthly maintenance kits dated 20 jan 2014 or later will contain acceptable tubing. the manufacturer’s investigation determined there was a difference in the rigidity in some of the peristaltic pump tubing. tubing that is more rigid does not allow for proper fluid transfer and may result in flooding or peristaltic pump tubing fluid related errors. the manufacturer advises users of the followings: call local representatives to arrange replacement of the remaining monthly maintenance kit(s) (part no. ct9554). it is acceptable to continue to use the existing inventory of peristaltic pump tubing until replacement order arrives. discard the remaining inventory of monthly maintenance kit(s) and peristaltic pump tubing upon receipt of replacement order. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 22 january 2014.

Device

CELLTRACKS AUTOPREP System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cell Search CELLTRACKS AUTOPREP System
  • Manufacturer
    Cell Search

Manufacturer

Cell Search