Events

Alerta De Seguridad para MicroJect Ambulatory Pumps: (1) Model 30 Continuous Low Flow, (2) Model 200 Intermittent or Continuous Flow. Reference Nos .: (1) 220039, (2) 220041; Nos. Ser.: (1) 37037 to 64215, (2) 40069 to 64008; all pumps were manufactured on 1 May 2000, on 19 November 2001.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Sorenson 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
  • ID del evento
    695
  • Fecha
    2003-03-07
  • 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
    Insufficient infusion and separation between the pump and the enclosure / protection box may occur with the ambulatory infusion pumps mentioned above. the manufacturer initiated a "recall" by letter dated august 23, 2002.
  • Acción
    Make sure you received the letter from Sorenson Medical on August 23, 2002. Identify and isolate any affected product in your inventory. The manufacturer declares that it has implemented corrective actions to prevent a recurrence of the problem. Corrective action has been performed for MicroJet pumps distributed after August 23, 2002. For additional information, contact Sorenson Medical in the USA at (801) 352-1888. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

MicroJect Ambulatory Pumps: (1) Model 30 Continuous Low Flow, (2) Model 200 Intermittent or Conti...

Manufacturer

Sorenson Medical
  • Source
    ANVSANVISA