Events

Alerte De Sécurité sur BAXTER INFUSORS. ANVISA Register No. 10068390348. Products under risk: all lots for the last 3 years (codes: 2C1071KJP, 2C1075KJP, 2C1080KJP, 2C1082KJ, 2C1156KP, 2C1163KP, 2C1087KP, 2C1008KP, 2C1009KP and 2C1954KJP).

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 BAXTER HEALTHCARE CORPORATION; BAXTER HOSPITALAR LTDA..

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
    1293
  • Date
    2013-09-13
  • 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
    The production plant received 225 complaints related to the infusion rate greater than that intended, involving the elastomeric systems in question. According to the company, health care providers must continue to follow the instructions for use of the product to avoid the occurrence of changes in infusion rates - see attached details. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Cause
    Claims related to infusion flow velocity greater than those intended for this type of device (elastomeric infusor).
  • Action
    Baxter has issued Safety Alert for its customers, alerting to the importance of following the instructions of use of the product. See attached details.

Device

BAXTER INFUSORS. ANVISA Register No. 10068390348. Products under risk: all lots for the last 3 ye...

Manufacturer

BAXTER HEALTHCARE CORPORATION; BAXTER HOSPITALAR LTDA.