Alerta De Seguridad para INFUSOMAT SPACE INFUSION PUMP (Registro Anvisa: 80136990568).

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.

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.