Events

Alerta De Seguridad para MARS Kit Gambro, Type 1116/1-X-MARS

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
    2018-01-03
  • Fecha de publicación del evento
    2018-01-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180103a.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 healthcare mars kit gambro, type 1116/1-x-mars medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its mars kit gambro, type 1116/1-x-mars [product code: 800540; lot numbers (expiration date): 22651 (01 september 2019), 22708 (30 september 2019)]. the manufacturer has received customer complaints regarding leakage in the albumin circuit. the leakage was caused by an inadequate adhesive connection of the tubing to the hansen connector of the mars tube set which is part of the mars treatment kit. according to the manufacturer, an undetected leaking albumin circuit could lead to excessive fluid removal from the patient during albumin dialysis. this could lead to hypovolemia. delay or interruption of therapy may also occur if the issue is detected during priming. the manufacturer has not received any reports of adverse events or patient injury associated with this issue. affected users are advised to locate and remove all affected product from facility. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 03 january 2018.

Device

MARS Kit Gambro, Type 1116/1-X-MARS
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Healthcare MARS Kit Gambro, Type 1116/1-X-MARS
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare