Alerta De Seguridad para LINEAR ST 1000 PERISTÁTICA PUMP SET. ANVISA Registration No. 10188530043. Units affected: 30030M / 00 to 42955M / 00.

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.

Inconsistency was identified in the end of infusion alarm when a second user programming was performed without disconnecting the equipment between the first and second programming. In the second programming condition, the end of infusion alarm is triggered once, restarted every 5 seconds after 15 minutes of termination of the infusion. In both situations, the "infusion end-of-alarm" audible / visual alert is normally triggered every 1 minute during the last 4 minutes of infusion, and the device enters the KVO situation with constant visual indication (display of 7 segments and LCD diplay). Additional information may be obtained from your product vendor or from cte@samtronic.com. UPDATE 2/5/2015 - The company on 04/17/2013 forwarded a report of completion of the action as foreseen in RDC 23/2012.