Alerte De Sécurité sur Trade name: Spectra Optia Apheresis System. Technical Name: Apheresis System. ANVISA registration number: 80554210002. Class of risk: III. Model affected: -. Batched / affected series numbers: All devices.

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..

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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.

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  • Type d'événement
    Safety alert
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • 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
    Recommendations for users: 1) Distribute this notification to all users of the Spectra Optia Apheresis System within their organizations. 2) Review the supplement of the operator's manual attached to this letter with all users of the Spetra Optia Apheresis System, making it available for consultation whenever necessary. 3) Continue to use the Spectra Optia Apheresis Systems as instructed in the Operator's Manual and supplement contained in this letter. 4) Important: Fill in the receipt form (Annex II - Receipt Confirmation Form) and send it signed to the email as soon as possible and before 05/31/2018. Sending this completed and signed form is essential to ensure that the information in this security alert has been received by all users. 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: 01/31/2018 - Date of notification notice to Anvisa: 05/02/2018 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
    The company, while testing a new software version (12.0), coupled a blood warmer on the spectra optia atherapy system in the "start run" phase and found that it did not readily appear on the screen for the operator to connect and prepare the blood heater. if the operator stops preparing the blood warmer before connecting to the patient and starting or resuming the procedure, air can be infused into the patient.
  • Action
    Field Action Code FA 27 triggered under the responsibility of the company Terumo BCT Tecnologia Médica LTDA. Updating, correcting or supplementing the instructions for use.