Events

Alerte De Sécurité sur BAXTER LONG PERMANENCE TWIST-CLAMP 6 TRANSFER EQUIPMENT, Hazard Class II, Brand: Baxter, Record: 10068390005, code 5C4482, all existing batches.

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 Ltda.; Baxter Healthcare Corporation.

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
    1728
  • Date
    2015-10-30
  • 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
    According to the manufacturer's information, the risk of improper use of transfer equipment for peritoneal dialysis may result in contamination. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Identified absence of information on product label.
  • Action
    Update of the instructions for use. The recommendation will be included on the label to monitor the function of the thyroid in nursing or child patients, as there is the remote risk of change. The need to use aseptic technique in order to avoid contamination leading to infection or peritonitis will be reinforced. Changes to the instructions for use include: • This equipment should be used with the Baxter Titanium Adapter for the peritoneal dialysis catheter for disconnection and for connections to the Homechoice cycler where aseptic connections and disconnections are made at the junction of the extension of the catheter; //// • For connection and exchange of the Equipment, the Transfer Team Exchange technique provided by the Baxter Clinic Team must be followed. ///// It is recommended that thyroid function be monitored in patients with small volumes of peritoneal dialysate filling, typically infants or children; //// Reprocessing or reusing single use equipment can lead to contamination and impairment of the function or structural integrity of the equipment; /// Do not use if the guards are not in place; //// This product does not contain natural rubber latex. ////////// Baxter requests that patients be advised by clinics and hospitals about these changes that will be made in the instructions for use and that the importance of following the instructions for use of the products is emphasized. (SEE LETTER TO THE CLIENT). Action code: FCA2013-013

Device

BAXTER LONG PERMANENCE TWIST-CLAMP 6 TRANSFER EQUIPMENT, Hazard Class II, Brand: Baxter, Record: ...

Manufacturer

Baxter Hospitalar Ltda.; Baxter Healthcare Corporation