Alerta De Seguridad para "Pocket" System Controller used with the HeartMate II Left Ventricular Assist System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Thoratec 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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: backup battery expiration for "pocket" system controller used with the heartmate ii left ventricular assist system the united states food and drug administration (fda) has issued a medical device safety alert concerning backup battery expiration for "pocket" system controller used with heartmate ii left ventricular assist system (lvas), manufactured by thoratec corporation. the serial number on the system controller started with the letters "pc". the manufacturer issued a voluntary urgent medical device correction letter to all hospitals which have patients supported with the heartmate ii lvas reminding them to monitor the expiration date of the backup battery contained within the heartmate ii "pocket" system controllers, as specified in the product instructions for use (ifu). according to the manufacturer, this backup battery has a 36 month expiration date; an advisory alarm, indicated by a yellow wrench symbol, is triggered at 12:00 a.M. on the first day of the month in which the backup battery expires. it is important to note that exceeding the backup battery expiration and any associated advisory alarms do not affect normal heartmate ii lvas function. while the ifu of heartmate ii lvas provides information on monitoring and changing the backup battery before it reaches the 36 month expiration date, the manufacturer has recently received reports from several hospitals about a number of patients who encountered an advisory alarm due to the expiration of their system controller backup batteries. some of these patients who received the advisory alarm attempted to switch from their primary to backup system controllers, and of those, three were unable to connect their pumps to their backup system controllers in a timely manner, resulting in two patient deaths and one serious injury. the manufacturer is working with hospital staff to identify patients that may be close to reaching the 36-month expiration date of their system controller backup batteries in order to facilitate priority replacement and to ensure routine monitoring of backup battery lifetime during clinic visits, as specified in the product ifu. the manufacturer also advises the patients who received the affected products with certain serial number and experienced an advisory alarm should contact their doctors or hospitals for further instructions and do not attempt to replace the system controllers unless otherwise instructed. for details, please refer to the fda website:http://www.Fda.Gov/safety/recalls/ucm462627.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 september 2015.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Backup battery expiration for "Pocket" System Controller used with the HeartMate II Left Ventricular Assist System
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source