Events

Alerta De Seguridad para INFUSION PUMPS IVAC MEDSYSTEM III: (1) MODEL 2860, (2) MODEL 2863, (3) MODEL 2865, (4) MODEL 2866 INTERNATIONAL, (5) MODEL MINIMED III SIEMENS MMT 9500. UNITS CONTAINING ASSEMBLY OF MODULE DRIVE AND THE ENGINE KIT WITH DATA CODE 448.

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
    72
  • Fecha
    2001-05-18
  • 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 assembly of drive modules and the motor kit with data code 448, in the referred infusion pump, may be associated with the proportion of early deterioration of the engine switch. alaris issued a safety alert of the referred infusion pump, emphasizing the importance of the periodic maintenance services as necessary and the corrections that the operator should follow according to the service manual. alaris warns that if there is false alarm with the pump, proper correction should be performed before using it in another patient, because false alarms may indicate that something in the pump is showing aging signs, incorrect alignment, failure, need of cleaning, etc. alaris issued the 471 service bulletin to customers in december 2000.
  • Acción
    MAKE SURE YOU HAVE RECEIVED THE LETTER OF DECEMBER 2000 FROM ALARIS WITH SERVICE BULLETIN 471. ALARIS AFFIRMS THAT THIS BULLETIN DOES NOT REQUIRE IMMEDIATE ACTION BY CLINICAL ENGINEERS BUT SHOULD BE INCORPORATED IN THE ROUTINES OF THE HABITAL MAINTENANCE SERVICES OF THESE PRODUCTS. IF YOUR INSTITUTION PERFORMS ITS OWN MAINTENANCE ROUTE AND NEEDS THE NEW SERVICE MANUAL, CONTACT ALARIS BY PHONE 0021-1-858-458-6003. FOR TECHNICAL INFORMATION REGARDING THE PERFORMANCE, OPERATION OR CORRECTION OF THE ALARIS PRODUCTS, CONTACT THE ALARIS MEDICAL SYSTEMS TECHNICAL SERVICE BY PHONE 0021-1-858-458-6003 WHEN YOU NEED.

Device

INFUSION PUMPS IVAC MEDSYSTEM III: (1) MODEL 2860, (2) MODEL 2863, (3) MODEL 2865, (4) MODEL 2866...

Manufacturer

ALARIS MEDICAL SYSTEMS INC.
  • Source
    ANVSANVISA