Alerta De Seguridad para CONTINUUM INFUSION SYSTEM, MIK codes 200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, 3015160 and 3015161. Anvisa Registry No. 80172890011.

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.

According to the record holder, the accuracy of the Continuous Infusion system is defined in the product specification contained in the operating manual (+/- 10% +/- 2C). Technical complaints received by the company claim sub-dose and root cause analysis determined variations in infusion characteristics attributed to variation in elasticity property and resistance of the connectors, which can directly affect system performance. Tests performed indicate that the connector exhibits a higher glass transition temperature and is significantly more rigid at room temperature, resulting in a material having an undesirable elastic property and which, when used as part of an infusion mechanism, exhibits significant variation relative to the flow rate accuracy (outside the accuracy limit of +/- 10%). A risk study was conducted by the company to evaluate technical complaints and there are two risk scenarios associated with this situation: Scenario 1: The operator realizes that the patient is not receiving the volume and flow rate programmed during or after the procedure. The completion of this risk assessment has an unacceptable level of safety; Scenario 2: The Biomedical engineer examines the accuracy of the pump before performing the procedure and based on the error presented the procedure is not performed. The completion of this scenario is within acceptable security level. For additional information, consult the alert message issued by the company at http://portal.anvisa.gov.br/wps/wcm/connect/5459c9004b44c2949a6e9aaf8fded4db/Alerta_1133_Apenta_Messagem.pdf?MOD=AJPERES.