Events

Alerta De Seguridad para CADD Administration Sets with Flow Stop

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

¿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
    2016-05-10
  • Fecha de publicación del evento
    2016-05-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160510a.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: smiths medical cadd administration sets with flow stop medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its cadd administration sets with flow stop. the following products re-order numbers for devices with a device expiration date on or before march 2021 are affected: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24]. the affected products have the potential to impact flow rate when used with a variety of cadd ambulatory infusion pumps. this may result in under delivery of medication. the manufacturer’s test data indicates that under infusion has the potential to contribute to an average of an additional 5.2% under delivery beyond the +/- 6% stated in the operator’s manual for the cadd pumps. the manufacturer’s risk analysis identified the following possible serious adverse health consequences with a very remote probability of occurrence: 1) inadequate symptom control (dependent on therapy being delivered). for example: increase in pain or increase in cardiac symptoms (heart rate, rhythm, blood pressure); 2) inadequate treatment (dependent on therapy being delivered). for example: subtherapeutic doses delivered of medication in which a specific volume needs to be infused such as antibiotics, chemotherapy, or nutritional therapy. the manufacturer concluded that there is a very remote probability that under delivery may occur resulting in patient harm, as all possible levels of patient harm were evaluated to be rare. the manufacturer is not requesting return of product. the manufacture advises users to continue to monitor for under delivery when utilising the cadd administration sets with flow stop. according to the manufacturer, 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 10 may 2016.

Device

CADD Administration Sets with Flow Stop
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smiths Medical CADD Administration Sets with Flow Stop Free
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical