Events

Safety Alert for BAXTER LONG PERMANENCE TWIST-CLAMP 6 TRANSFER EQUIPMENT, Hazard Class II, Brand: Baxter, Record: 10068390005, code 5C4482, all existing batches.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda.; Baxter Healthcare Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1728
  • Date
    2015-10-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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