Events

Alerte De Sécurité sur MicroJect Ambulatory Pumps: (1) Model 30 Continuous Low Flow, (2) Model 200 Intermittent or Continuous Flow. Reference Nos .: (1) 220039, (2) 220041; Nos. Ser.: (1) 37037 to 64215, (2) 40069 to 64008; all pumps were manufactured on 1 May 2000, on 19 November 2001.

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 Sorenson Medical.

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
    695
  • Date
    2003-03-07
  • 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
    Insufficient infusion and separation between the pump and the enclosure / protection box may occur with the ambulatory infusion pumps mentioned above. the manufacturer initiated a "recall" by letter dated august 23, 2002.
  • Action
    Make sure you received the letter from Sorenson Medical on August 23, 2002. Identify and isolate any affected product in your inventory. The manufacturer declares that it has implemented corrective actions to prevent a recurrence of the problem. Corrective action has been performed for MicroJet pumps distributed after August 23, 2002. For additional information, contact Sorenson Medical in the USA at (801) 352-1888. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

MicroJect Ambulatory Pumps: (1) Model 30 Continuous Low Flow, (2) Model 200 Intermittent or Conti...

Manufacturer

Sorenson Medical
  • Source
    ANVSANVISA