Events

Alerte De Sécurité sur Hypothermia / Hypertemia System HCU 40 Technical Name: Body Temperature Control Equipment ANVISA Registration Number: 10390690089 Hazard Class: III Model Affected: HCU 40 Serial Numbers Affected: 90440288 and 90440289

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 MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO 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
    2257
  • Date
    2017-04-03
  • 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
    • Upgrading your HCU 40 systems must be performed by Maquet's authorized service personnel in accordance with Upgrade Instruction - FSCA-2016-11-30 - Heating-Cooling Unit HCU 40 (MCV-UI-10000833-EN- 01) as soon as possible. • Complete the attached Recognition Form and return it as soon as possible to your local Maquet representative. • Incorporate the new cleaning and disinfection procedures into your operation processes, and perform any necessary training. • Continue to monitor hygiene (levels of contamination) according to your internal practices. • Immediately report any contamination findings to your local Maquet representative by filing a complaint.
  • Cause
    Maquet cardiopulmonary, as well as different competent national authorities, received isolated reports indicating bacterial contamination in the hcu 40 system water, including mycobacterial counts. maquet has not received any reports that a mycobacterial infection has been caused by a hcu 40. our investigations have shown that the currently published disinfection procedure of the hcu 40 system waterways (in the instructions for use) should be improved as to effectiveness against atypical mycobacteria. in this context, it is important to know that a hazard to the patient due to escape of microorganisms during the operation of the heating-cooling unit hcu 40 can be excluded with near absolute certainty. an independent testing institute also concluded that.
  • Action
    Field Action Code FSCA-2016-11-30 triggered under the responsibility of the company MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA. Company will make correction in the field.

Device

Hypothermia / Hypertemia System HCU 40 Technical Name: Body Temperature Control Equipment ANVISA ...

Manufacturer

MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA.
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    ANVSANVISA