Events

Alerta De Seguridad para Product name: Prismaflex Technical Name: Hemodialysis Device ANVISA Registration Number: 80145240438 Hazard Class: III Serial numbers Affected: 107493/113082/114489

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Hospitalar; Gambro Lundia AB Suécia.

¿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
  • ID del evento
    2254
  • Fecha
    2017-03-28
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    The Prismaflex machine has been designed with specific features to ensure that device operators safely disconnect patients before removing the filter lines after treatment. Operator's manual instructions, which appear on the machine's screen, require that before disconnecting the patient, the operator must: 1. Tighten all lines; 2. Disconnect blood line from access and return blood access equipment and; 3. Check that all lines are pinched and that the patient is disconnected from the equipment. Baxter will voluntarily offer an updated version of the software (8.10) with additional safety measures with the introduction of yet another automated test so that the operator never disconnects the patient without pinching all blood access and return lines . This upgrade will not cost the customer.
  • Causa
    Baxter brazil received reports of misuse situations outside brazil (europe and south africa), involving operators of prismaflex machines who did not follow the instructions for use regarding the safe removal of the disposable prismaflex kits from their units. control, necessary steps to disconnect the patient safely before removing the prismaflex kit from the machine after treatment. failure to do so may result in severe blood loss. although this is a misuse and in order to prevent these situations from occurring, baxter will voluntarily offer an updated version of the software (8.10) of the equipment, with additional security measures, with the introduction of another automated test, so that the operator never disconnects the patient without having pinched all the lines of access and return of blood. this upgrade will not cost the customer.
  • Acción
    Field Action Code FA 2017-002 triggered under the responsibility of the company Baxter Hospitalar. Company will update, correct or supplement the instructions for use.

Device

Product name: Prismaflex Technical Name: Hemodialysis Device ANVISA Registration Number: 80145240...

Manufacturer

Baxter Hospitalar; Gambro Lundia AB Suécia