Events

Alerta De Seguridad para Infusion pumps Alaris IVAC (1) Model 597, (2) Model D598

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Alaris Medical Systems Inc.

¿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
    237
  • Fecha
    2000-12-22
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The uk medical devices agency (mda) has issued a safety note informing hospitals that it continues to receive reports of high doses of infusion resulting from user-free flowing by mismanaging the devices of the pumps mentioned. the mda states that poorly handled apparatus can interfere with the pump mechanism, resulting in a free flow at the start of the infusion. while the infusion happens the assembly positions correctly and the fluid adjusts to the set of programmed instructions. the mda states that in such cases, even if the user can detect the high doses of infusion by examining the amount of fluid in the bag, the inadequate loading will not be detected, since the assembly will not be properly positioned. in addition, the infused volume display will not show the wrong extra volume due to the initial free-flow.
  • Acción
    MDA recommends the following: (1) Ensure that the assembly loading instructions are followed at the time of fitting of the equipment in the Pump Models 597 and 598. (2) Do not operate the orange lock before the lower set adapter is fully inserted into the air-in-line switch. (3) Do not close the door before operating the orange latch. (4) Make sure that no fluid is present and that no drop is dripping into the chamber at the time of opening of the assembly clamp prior to the start of infusion. For further factory information, contact your local representative or directly with Carlos Sepulveda, Alaris Medical Systems, by mail at the above address, by phone / fax 0021-44-2- (125) 633 0860 ..

Device

Infusion pumps Alaris IVAC (1) Model 597, (2) Model D598

Manufacturer

Alaris Medical Systems Inc
  • Source
    ANVSANVISA