Events

Safety Alert for Technical Name: CENTRIFUGAL PUMP FOR CARDIOPULMONARY BY-PASS SYSTEM Registration Number: 80102511251 Hazard Class: III Model Affected: S5, C5 Serial Numbers Affected: NS 16S15049 and 16S15050

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR Medical Importadora e Distribuidora de Prods Médicos Ltda; LivaNova Deustchland GmBH (previously Sorin Deustchland GmbH).

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
    2286
  • Date
    2017-05-15
  • 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
    VR Medical does not have complaints records of the Ação products, since its installation is recent in the country, but we recommend that the professionals carry out
  • Reason
    Livanova detected risks of contamination by mycobacterium during cardiac surgeries when using the sorin - livanova coolant devices by the 3t heater / cooler when it is not subject to the cleaning and decontamination procedures recommended by the manufacturer. said heather cooler (heater / cooler) is an accessory in the perfusion system product registered by vr medical in brazil.
  • Action
    Field Action Code AC006 / 17 triggered under the responsibility of the company VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA. Company will make correction in the field.

Device

Technical Name: CENTRIFUGAL PUMP FOR CARDIOPULMONARY BY-PASS SYSTEM Registration Number: 80102511...

Manufacturer

VR Medical Importadora e Distribuidora de Prods Médicos Ltda; LivaNova Deustchland GmBH (previous...
  • Source
    ANVSANVISA