Safety Alert for LINEAR ST 1000 PERISTÁTICA PUMP SET. ANVISA Registration No. 10188530043. Units affected: 30030M / 00 to 42955M / 00.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by SAMTRONIC INDÚSTRIA E COMÉRCIO LTDA. CNPJ: 58426628/0001-33. End.: Rua Venda da Esperança, São Paulo - SP. CEP: 04763-040 Tel: (11) 2244-7760 / FAX: (11) 2244-7751..

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
    1186
  • Date
    2012-10-02
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    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.
  • Reason
    Inconsistency in the end-of-infusion alarm.
  • Action
    The company recently started field action for software correction (replacing version V1.10 with new version V1.20), with an expected completion on 01/31/2013. As a palliative action, before the correction is implemented, the company is sending a letter of orientation to its clients directing them to turn off and on the equipment if there is a need to reprogram the infusion (see letter to clients at http: //portal.anvisa .gov.br / wps / wcm / connect / a4e033004cef92f9ba30ba551355428f / Carta + ao + Cliente_02_10_2012.pdf? MOD = AJPERES).