Events

Safety Alert for PUMP FOR INFUSION OF ENTERAL NUTRITION - MOD. APPLIX SMART and APLLIX VISION.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Fresenius Vial.

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
    910
  • Date
    2008-04-17
  • 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
    The company Fresenius Kabi Brasil Ltda informed in a letter of communication sent to the Anvisa's Unit of Technovigilance that it will be sending letters of communication to clarify to its clients about the correct positioning of the equipment in the infusion pumps for enteral feeding. The company also informed that it will be providing to GQUIP / ANVISA (Equipment Technology Management) to change the legal information of use instructions contained in the Product Use Manual.
  • Reason
    If the equipment is improperly adjusted in the pump, there is a risk of free flow of fluid and consequent overdosage of enteral nutrition.
  • Action
    UTVIG / ANVISA recommends that persons responsible for the use of pumps: (1) Identify the products listed in their inventory; (2) Check whether all those directly involved in the operation of the infusion pumps (doctors, nurses, patient's relatives, etc.) are adequately trained; (3) Ensure that the instructions contained in the user manual are available and easily accessible to the pump operators; (4) Ensure that pump operators are performing visual inspection of these equipment and recording any observed nonconformities; (5) Ensure that pump operators are following the manufacturer's instructions for installation of the equipment (see Annex 01).

Device

PUMP FOR INFUSION OF ENTERAL NUTRITION - MOD. APPLIX SMART and APLLIX VISION.

Manufacturer

Fresenius Vial