Events

Alerta De Seguridad para Ipump Patient-Controlled Infusion Pump. Distributed units in the US and Canada, Europe, New Zealand and Singapore

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Healthcare Corp.

¿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
    375
  • 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
    An ecri member hospital reported that when one of the above pumps in its inventory was turned off (turned off) and then (reactivated) reclosed in the same patient, the pump returned the patient's original prescription instead of adjustments made during therapy. the problem has occurred on many occasions and has led to the highest medication for the patient.
  • Acción
    ECRI states that the user has two options when turning the Ipump infusion pump back on: (1) they can clean the pump and reprogram it to the next patient, or (2) they can use the "Previous Prescription" function? ¿(Previous RX? ¿) To reverse the originally programmed pump prescription. ANVISA and ECRI recommend the following: (1) to alert all staff who program the Baxter Ipump infusion pump of this problem and notify ANVISA. Explain to the team how the function "Previous RX" works. (2) Instruct the staff clearly about all current settings (operation) before the Ipump infusion pump is deactivated during therapy. When the pump is activated back (again), the team must reprogram it with these settings and confirm these settings before resuming therapy. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Ipump Patient-Controlled Infusion Pump. Distributed units in the US and Canada, Europe, New Zeala...

Manufacturer

Baxter Healthcare Corp
  • Source
    ANVSANVISA