Events

Safety Alert for INFUSOMAT SPACE INFUSION PUMP (Registro Anvisa: 80136990568).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A.; B. Braun Melsungen AG..

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
    1050
  • Date
    2011-02-25
  • 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
    During the installation of the equipment in the pump, if the user ignores the instructions for use and fails to insert the safety clamp correctly, the equipment will issue an alert (yellow light) signaling the installation error. If the user ignores the alert signal and proceeds by closing the front door of the infusion pump, a second warning signal will be displayed on the display "Infusion Line Change - Keep the Closed Drops Regulator!". If, however, the user continues to attempt to program infusion parameters, the device will display the message "Open Port and Enter Line (Equipment) or Press 'C' to Enter Parameters". If the user insists on entering parameters, this sequence will be accepted by the equipment, and then, if the roller gripper is opened, gravity-free flow may occur to the patient. If this sequence of events occurs, the drip will be visible in the drip chamber and the operator will still have the opportunity to close the roller clamp manually and correct the clamp insert against free flow. According to the product registration holder, the instructions for correct use of the product are affixed to the front door of the product and are passed on to the training provided to users. The company informed that such information (instructions for use) will be reiterated through letters to customers. Anvisa's Technovigilance Unit is monitoring this case.
  • Reason
    Possibility of occurrence of free flow (by gravity) for the patient.
  • Action
    Users of the product should follow the instructions for inserting the safety clip, which are affixed to the front door of the product. The health facility is advised to advise its employees of the problem in question, guiding them to follow the handling instructions correctly in order to avoid the occurrence of the problem mentioned in this alert. According to the product registration holder (Laboratorios B. Braun SA), the manufacturer (B. Braun Melsungen AG) has already initiated actions in order to implement a more efficient and safe infusion line occlusion system for infusion pumps INFUSOMAT. According to the registry holder, such product update will occur in the next software release ("J" version).

Device

INFUSOMAT SPACE INFUSION PUMP (Registro Anvisa: 80136990568).

Manufacturer

Laboratórios B. Braun S.A.; B. Braun Melsungen AG.