Alerte De Sécurité sur Trade name: Synchromed II Implanted Infusion Pump. Technical Name: Surgical Focus. ANVISA Registration Number: 80259119002. Hazard Class: I. Model Affected: HLX 3004-3005. Affected serial numbers: Vertical connection of the Acrobat 2000 articulated arms, manufactured between 2004 and 2006, equipping the HLX 2004-2005, HLX 3004-3005 and XTEN surgical lights.

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 Do Brasil Equipamentos Médicos Ltda; Maquet S.A.S. Avenue de la Pomme de Pin.

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
    2422
  • Date
    2017-12-01
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    This letter is to inform you of a corrective action consisting in the replacement of all potentially affected articulated arms still in use by the new ones. This action will be undertaken to prevent any possible danger to people and equipment. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 09/28/2017 - Date of notification notice to Anvisa: 01/12/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    From our investigation, it was concluded that there is a low failure rate that can only occur in the types and production devices identified in this letter. the problem is related to a crack in the metal of the articulated arms, which has the potential to develop a break. the devices are over ten years old, and yet the vast majority of them have not failed. we received related complaints; however, to date, no event involving injuries has been reported to us. please be advised that the product is no longer marketed to the brazilian market due to discontinuation.
  • Action
    Field Action Code MSA / 2017/002 / IU triggered under the responsibility of Maquet Do Brasil Equipamentos Médicos Ltda. Will make correction in the field.

Manufacturer