Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ALARIS MEDICAL SYSTEMS INC..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    72
  • Date
    2001-05-18
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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.
  • Action
    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