Events

Alerta De Seguridad para Advanced Perfusion System 1

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

¿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
    2012-09-14
  • Fecha de publicación del evento
    2012-09-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120914.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: silicone tracheostomy tubes medical device manufacturer, terumo cardiovascular systems (cvs) has issued a field safety corrective action regarding the recall of flow module for terumo advanced perfusion system 1 [catalogue no.: 802018; serial number range: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, 00823-00847. the manufacturer received two reports of random flow readings and/or intermittent false back flow alarms for the terumo advanced perfusion system 1 when there was no tubing in the flow sensor. when operating as intended, the module will generate '---' (three dashes) in the display, and issue a ‘check sensor’ alert message, when there is no tubing in the flow sensor. the manufacturer’s investigation found that: the malfunction was caused by an improperly set voltage level in a population of circuit boards used in the flow modules for terumo system 1. the module operates correctly if tubing is installed. this failure of the flow module is expected to occur very rarely in the affected population and is easily detectable. besides, the failure only occurs when there is no tubing installed in the flow sensor and therefore the only risk to the patient is if the failure results in operator confusion, distraction or a delay of surgical procedure. there are no known reports of patient injury as a result of this issue. the manufacturer has decided to replace all flow modules in the affected population. users can continue to use their flow modules while awaiting replacement. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 september 2012.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation