Alerta De Seguridad para HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)

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

¿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
    2013-04-10
  • Fecha de publicación del evento
    2013-04-10
  • País del evento
  • Fuente del evento
    DH
  • 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: baxter homechoice automated peritoneal dialysis system (ac power cord set) medical device manufacturer, baxter healthcare, has initiated a medical device field safety correction action concerning homechoice automated peritoneal dialysis (pd) system (product code 5c4474). following a recent review, baxter has become aware of a modification carried out to the ac power cords used on homechoice automated pd devices. the modification has involved fitting of a local ac plug which could affect the integrity of the ac power cord set in use. although all power cords for homechoice device currently using in hong kong fulfill the standard bs1363 and follow the guideline of hong kong electrical and mechanical services department, the overall integrity of these power cords is uncertain. it is baxter’s intention to replace it with an approved version power cord over the coming 12 months. there are two potential risks to the user. firstly, the device may fail to function and the dialysis session will be delayed. secondly there is a potential for an electrical fire or shock to occur, which may result in burns or cardiac death in extremely rare case. baxter has already developed an approved power cord to suit multi-countries requirements with an integral plug for use on homechoice pd system. also, baxter technical service engineers will replace ac power cords for the homechoice device in the facility and patient’s home during the next onsite maintenance. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 april 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)
  • Manufacturer

Manufacturer