Events

Alerta De Seguridad para MedSystem III Infusion Pump

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
    366
  • Fecha
    2001-12-30
  • 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
    A hospital member of ecri reported that the low dosage can only be programmed within the pump calculator is 0.1mcg / kg / min; however, some of these drugs used (eg, fenoldopam, isoproterenol, norepinephrine) have a dosage range below 0.1 mcg / kg / min.
  • Acción
    For most infusions, the drug dose calculator on the MedSystem III infusion pump has sufficient resolution; however, for doses below 0.1 mcg / kg / 1min, the calculator should not be used. In these cases, the clinician should use another calculator with sufficient resolution and then place the correct measurement on the pump. In cases where these calculations must be done regularly an appropriate backup calculator should be well on hand. In addition, whenever a user does the calculation manually, another team member should confirm them before programming the pump. For more information, contact ANVISA's Technovigilance Unit, by phone at (61) 448-1485. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

MedSystem III Infusion Pump

Manufacturer

ALARIS Medical Systems Inc
  • Source
    ANVSANVISA