Events

Alerta De Seguridad para Venisystems Blood Bottle Pumpset with CAIR Clamp

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

¿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
    2013-11-18
  • Fecha de publicación del evento
    2013-11-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131118a.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 venisystems blood bottle pumpset with cair clamp it has come to our attention that medical device manufacturer, hospira, has initiated a field safety corrective action concerning venisystems blood bottle pumpset with cair clamp. the details of the affected devices are as follows: list number: a) 04643-97-01; b) 12697-65; c) 12720-65 lot number: a) 040945g, 131335g; b) 281145h, 180015h, 040115h, 880485h, 782245h, 680585h; c) 161475h, 153405h, 032595h there are increased complaints of backflow of fluid, incorrect assembly and no flow associated with the affected intravenous administration sets, which have resulted in retrograde flow. incorrect assembly of the bulb pump has the potential to prevent delivery of blood to the patient resulting in a delay of therapy. it may result in death or serious injury if a prolonged delay in the administration of life-sustaining blood products occurs. no reports of injury to patients have been received to date. the manufacturer advises users not to use and immediately quarantine the affected products, and return them to the manufacturer. hospira is improving the manufacturing process to address incorrect assembly. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2013.

Device

Venisystems Blood Bottle Pumpset with CAIR Clamp
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hospira Venisystems Blood Bottle Pumpset with CAIR Clamp
  • Manufacturer
    Hospira

Manufacturer

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