Events

Alerta De Seguridad para Gemstar Docking Station

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

¿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
    2013-11-05
  • Fecha de publicación del evento
    2013-11-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131105a.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: hospira gemstar docking station the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning gemstar docking station (list numbers 13075-xx-07, 13075-xx-09) manufactured by hospira inc. two problems may occur when the above gemstar docking station is used with gemstar pumps and external battery pack. first, when the docking station is used with a gemstar phase 3 infusion pump (list numbers 13000-xx, 13100-xx or 13150-xx) the pump may fail to power up while connected to the docking station. second, when the docking station is used with a gemstar phase 4 infusion pump (list numbers 13086-xx, 13087-xx or 13088-xx) and an external battery pack (list number 13073-xx) the pump may display error code 11/003 indicating excessive input voltage from the external sources. the 11/003 error code will stop infusion if it occurs while an infusion is in progress. as a delay of therapy may occur which can result in patient injuries, hospira advises users to: use two fresh internal aa batteries if a failure to power up occurs. remove the battery pack prior to installing the pump into the docking station in order to mitigate the potential for an 11/003 error code. report to hospira if their pumps experience a failure to power up or an 11/003 error code. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 november 2013.

Device

Gemstar Docking Station

Manufacturer

Hospira Inc
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DH