Events

Alerta De Seguridad para HomeChoice Pro Automated Peritoneal Dialysis System

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
    2013-11-04
  • Fecha de publicación del evento
    2013-11-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131104a.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: baxter homechoice pro automated peritoneal dialysis system the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning homechoice pro automated peritoneal dialysis (apd) system manufactured by baxter healthcare. products with product code r5c8320 and the serial numbers 300905, 300882, 300928, 300889 are affected. there is a potential issue with the occluder assembly of homechoice pro devices. the blade of the occluder assembly is covered with a rubber boot. the occluder blade clamps the solution lines if a power failure occurs or when the cycler is off. this prevents uncontrolled solution delivery to the patient. an occluder failure will cause an unrecoverable slow flow/no flow alarm or an unrecoverable system error. the device will fail in a safe position and prevent solution from being delivered to the patient. baxter is informing the affected hospitals of the issue. hospitals will either notify affected patients or baxter will contact patients via homecare and arrange to swap the affected machines. baxter is also advising patients to perform manual peritoneal dialysis to continue therapy if there is an unrecoverable failure. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01117-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2013.

Device

HomeChoice Pro Automated Peritoneal Dialysis System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter HomeChoice Pro Automated Peritoneal Dialysis System
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare