Events

Alerte De Sécurité sur Hemodialysis machine model 1000, Anvisa registry nº 10068390356 and model SPS, registry Anvisa nº 10068390088.

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 Empresa Baxter Hospitar 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
    800
  • Date
    2005-01-27
  • 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
    Air in the blood line can cause gas embolism in hemodialysis patients. Issuance of letter to the clinicians responsible for the devices and hemodialysis therapy reporting of the corrective action to be performed in the manuals of the machine operator. If you have any questions, please contact Baxter technical support by calling 0800 12 55 22, option 3 or e-mail the national director of technical services, carmine_maglio@baxter.com. The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
  • Cause
    Reports of air bubbles were observed in the blood line, after the air detector, without sounding the alarm warning the operator of the possibility of air in the blood line.
  • Action
    One review showed inadequate use, including failures in the practices commonly observed in hemodialysis. The company informs that it has updated Operator's Manuals and training guides to clarify the instructions and add caution and caution phrases to call attention to the possibility of air entering the extracorporeal circuit and to clarify methods for withdrawing air from the circuit.

Device

Hemodialysis machine model 1000, Anvisa registry nº 10068390356 and model SPS, registry Anvisa nº...

Manufacturer

Empresa Baxter Hospitar Ltda
  • Source
    ANVSANVISA