Events

Alerte De Sécurité sur Information System, Distribution Information Program and Components of the Blood Bank Stand-Alone System. All versions up to and including version 1.1.1

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 Information Data Management.

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
    183
  • Date
    2000-10-27
  • 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 blood bank program mentioned has a defect that does not assign all special donation properties to all donated products. the manufacturer initiated a telephone recall on july 5, 2000, followed by letters sent on july 7, 11 and 17, 2000. the company did not provide any information to ecri.
  • Action
    Make sure that you have received the mailings that were sent on July 7, 2001 and July 7, 2000, by Information Data Management. Identify and isolate any affected product from your inventory. For more information, contact your local representative or directly with Information Data Management at 1 (847) 825-2300 in the United States. ECRI recommends that you do not use this system until the company corrects the protocol to ensure proper processing and documentation.

Device

Information System, Distribution Information Program and Components of the Blood Bank Stand-Alone...

Manufacturer

Information Data Management
  • Source
    ANVSANVISA