Events

Alerte De Sécurité sur Colleague Infusion Volumetric Pump, BAXTER Brand, Colleague Model, Colleague 3, Colleague CXE and Colleague CXE 3 - Registration Number 10068390320 /// Serial Number: 21120161DC, 22020018DC, 22030018DC, 22030000UC, 22040046UC, 22040071UC, 22040089UC, 22040104UC, 22050072DC, 22050406UC , 22060024DC, 22060720DC, 22060946DC, 22061138DC, 22061204DC, 22070050UC, 22070198UC and 22070444DC.

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 Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch..

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
    1510
  • Date
    2014-12-16
  • 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
    According to manufacturer's information, using the Colleague infusion pump with old wiring may result in an inaccurate time remaining battery level or the option to operate with battery power may become unavailable. In the event of a failure or event with the battery (which is extremely unlikely to occur), this situation could contribute to a delay in infusion or interruption of the infusion.
  • Cause
    According to the information disclosed by the company, 18 serial numbers of the colleague pump were identified that had the "yuasa" battery replaced during service, but battery wiring was not changed as required in the specification.
  • Action
    The company will correct the devices in the field and send Letter to the Client (SEE ANNEX) to those who have the equipment affected. Segregation of affected equipment is requested and completion of the Customer Response Form (APPENDIX). Once completed, send it to fax number 0 (XX) 11 5653-0106 or email faleconosco@baxter.com. LIST OF EQUIPMENT DISTRIBUTION IN ANNEX.

Device

Colleague Infusion Volumetric Pump, BAXTER Brand, Colleague Model, Colleague 3, Colleague CXE and...

Manufacturer

Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch.