Events

Alerta De Seguridad para MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp

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

¿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
    2014-05-15
  • Fecha de publicación del evento
    2014-05-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140515.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 minicap extended life peritoneal dialysis transfer set with twist clamp the australia therapeutic goods administration (tga) posted a medical device safety alert concerning minicap extended life peritoneal dialysis (pd) transfer set with twist clamp manufactured by baxter healthcare ltd. the affected product code is r5c4482 and only lot number h12f18054 is affected. the manufacturer has received complaints reporting connection issues between the pd transfer set catheter connector and an adapter with this lot number. connection issues between the pd transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis. the manufacturer advises hospitals and distributors to locate and return all the affected products at their facility. health professionals are asked to ensure that home patients are notified of this recall and identify patients who are currently using the affected lot for replacing the unused transfer sets with unaffected stock. for details, please refer to tga websites: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00536-2 and http://www.Tga.Gov.Au/safety/alerts-device-minicap-extended-life-pd-140515.Htm according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2014.

Device

MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd