Events

Alerta De Seguridad para ABBOTT ACCLAIM ENCORE INFUSION PUMPS

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LABORATÓRIOS ABBOTT PRODUTOS HOSPITALARES.

¿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
    21
  • Fecha
    2001-05-14
  • 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
    After an incorrect load of the pump administration package during operator training, the reference pump consistently restricts liquid release. the pump alarm was not sound to alert user of the problem. not ho.
  • Acción
    ECRI RECOMMENDS: (1) DO NOT BUY THE PUMP BECAUSE THERE IS PROBLEM POSITIONING THE PUMP MANAGEMENT ASSEMBLY, WHICH MAY CAUSE PATIENT SAFETY AT RISK. (2) IF YOU HAVE PURCHASED THIS PUMP, YOU MUST RETURN IT TO THE MANUFACTURER, BE REFUNDED OR EXCHANGE FOR ANOTHER MODEL. IF YOU NEED TO CONTINUE TO USE THIS PUMP, ECRI RECOMMENDS THE FOLLOWING: 1. ALERT STAFF IF THERE WAS INCORRECT CHARGING, THE PUMP ADMINISTRATION SET MAY RESTRICT THE RELEASE OF LIQUID OR EVEN FAIL TO RELEASE IT. IN ADDITION, IN THIS OCCASION, THE ALARM MAY NOT WORK TO NOTICE STAFF. 2O. ENSURE THAT ALL YOUR PERSONNEL WILL BE COMPLETELY TRAINED IN INSTALLING THE BOARD OF ADMINISTRATION. 3 MAKE SURE THAT ALL YOUR PERSONNEL ARE TRAINED TO VERIFY THAT THE ADMINISTRATION PIPE ASSEMBLY IS NOT STRETCHED AND THAT IS SECURELY COUPLED IN THE PUMP CHANNEL BEFORE CLOSING THE DOOR. 4 TRAIN YOUR PERSONNEL TO CHECK THE FLOW OF THE DROPS IN THE PUMP ADMINISTRATION CHAMBER, BEFORE LEAVING.

Device

ABBOTT ACCLAIM ENCORE INFUSION PUMPS

Manufacturer

LABORATÓRIOS ABBOTT PRODUTOS HOSPITALARES
  • Source
    ANVSANVISA