Events

Alerta De Seguridad para Advanced Perfusion System 1, Roller Pump

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

¿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
    2012-07-03
  • Fecha de publicación del evento
    2012-07-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120703d.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: terumo® advanced perfusion system 1, roller pump medical device manufacturer, terumo® cardiovascular systems (cvs) corporation, has issued an urgent field safety notice concerning terumor advanced perfusion system 1. the manufacturer has received reports of various roller pump malfunctions of the terumo® advanced perfusion system 1 that could result in the inability to use the pump and require the user to replace it with back-up equipment. the malfunctions included: unplanned pump stop,changes in pump speed and occlusion malfunctions. there are no known reports of serious patient injury as a result of these issues. terumo cvs' evaluation and/or initial investigation has determined that there are likely multiple root causes for the failures. it has initiated further investigation to determine exact root cause. as an interim precaution, the manufacturer is informing affecting users the risks associated with these failures, reminding them of the relevant instructions in the operator's manual, and providing an addendum to the operator's manual with additional instructions to be used during set-up to prevent occlusion malfunctions. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 july 2012.

Device

Advanced Perfusion System 1, Roller Pump
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Roller Pump
  • Manufacturer
    Terumo® Cardiovascular Systems

Manufacturer

Terumo® Cardiovascular Systems