Events

Alerte De Sécurité sur Trade name: ACCEL SYSTEM FOR COLLECTION OF BLOOD COMPONENTS Technical name: System for collection of blood components ANVISA registration number: 80554210015 Hazard class: III Affected model: ACCEL SYSTEM FOR COLLECTION OF BLOOD COMPONENTS

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 Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc..

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
    2203
  • Date
    2017-02-16
  • 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
    1) Distribute this notification to all Trima Accel System users within their organizations. 2) Review the supplement of the operator's manual attached to this chart with all users of the Trima Accel System, making it available for consultation whenever necessary. 3) Continue to use Trima Accel Systems as instructed in the operator's manual and supplement contained in this chart. 4) Important: Fill out the receipt form (Annex II - Receipt Confirmation Form) and send it signed to andrea.wecchi@terumobct.com as soon as possible and before 03/31/2017. Sending this completed and signed form is essential to ensure that the information in this security alert has been received by all users.
  • Cause
    Terumo bct issues this safety alert in order to inform users of the trima accel system that there is the possibility, however rare, of the iv pole column to download quickly when the release button is pressed. if a user does not hold the iv pole when lowering it, it may fall with intensity that would be sufficient in extreme cases to cause injury to the user if he, for example, keeps his hands on the path where the iv pole column goes down . terumo bct received only one report of an injury suffered by a user and other reports that the iv pole column is lowered quickly but without causing any damage. this possible safety risk exists with all trima accel system equipment in the following situation: if the user does not hold the iv pole column by pressing the release button, the iv pole column could descend freely. the force that the iv pole pole in free fall could cause injury if the hands or any other part of the user's body is in the downward path of the iv pole pole.
  • Action
    Field Action Code FA 30 triggered under the responsibility of the company Terumo BCT Tecnologia Médica LTDA. Company will update, correct or supplement the instructions for use.

Device

Trade name: ACCEL SYSTEM FOR COLLECTION OF BLOOD COMPONENTS Technical name: System for collection...

Manufacturer

Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc.