Alerte De Sécurité sur Trade name: Homechoice for peritoneal dialysis. Technical name: Homechoice Automated PD Cycle. ANVISA registration number: 10068390123. Class of risk: III. Affected Model: 5C4471. Serial number affected: 115V. . Trade name: Homechoice Claria. Technical name: Homechoice Claria APD System. ANVISA registration number: 80145240442. Class of risk: III. Model Affected: 5C6M10. Serial number affected: 115V / 230V

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; Baxter Healthcare Co..

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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
    Baxter is asking users / patients to take the following actions: 1. As stated in the Patient Guide, open the disposable set package by hand. Do not use knives, scissors, or other sharp objects to open the carton. 2. Be aware because the fluid flow out of the connector at the end of the patient's line after the therapy preparation phase is a visual indication of the potential for air entry due to an undetected hole in the patient's valve area at the casing coating. Baxter is updating the manual to include this information. 3. If you distribute this product to other facilities or departments within your institution, please forward a copy of this notice to them; 4. Complete the customer form attached to the letter and return it to Baxter via e-mail to or via fax to (xxx) 11 5635-0106 or 0800 012 5522. The prompt return of the response form to customer will prevent you from receiving this warning several times. 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: 06/16/2018 - Date of notification notice to Anvisa: 03/14/2018 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
    A baxter hospitalar ltda. is issuing this product information letter because it has been notified that some users were not following the instructions in the homechoice user manual and incorrectly opening the cassette pack while they are still configuring their peritoneal dialysis therapy, damaging the homechoice equipment cassettes or homechoice claria. the homechoice user manual specifically warns the user to open the package of the disposable set by hand and not to use tools that could damage the cassette. please do not use knives, scissors, or other objects to open the casing of the cassette equipment. if damaged cassettes are used, homechoice cyclists may not consistently detect small holes / product cuts in the patient's valve region and the cycler can introduce air into the patient.
  • Action
    Field Action Code FA - 2017 - 0017 triggered under the responsibility of the company Baxter Hospitalar. It will update and complement the instructions for use