Events

Safety Alert for Cannulas

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Sorin Group Usa Inc..

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
    R1706-251
  • Event Number
    2011DM-0007684
  • Date
    2017-06-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that due to an improvement in its monitoring process, it has found that some of the referenced devices may present an excess of plastic at the end of the cannula, if said excess is released during the use of the device it could result in the bloodstream, leading to potentially present adverse events on patients.

Device

Cannulas
  • Model / Serial
  • Product Description
    EASY FLOW AORTIC CANCER 23 fr 103-300. Aortic perfusion during cardiovascular surgical procedures that require extracorporeal cardiopulmonary bypass (CPB). EASY FLOW-ARTERIAL DUO CANNULA. WITH GUIDEWIRE 103-310. Extracorporeal circulation, RAP FEMORAL VENOUS CÁNULA 22 fr 200-100. Remote access transfusion. RAP FEMORAL VENOUS CÁNULA, 3/25 fr: 200-150. Remote access, femoral venous perfusion during cardiopulmonary bypass. FLEXFLOW VENOUS CANCER 23 fr 200-200: extracorporeal circulation. VASCULAR DILATOR KIT ESTECH: vascular insertion catheter or cannula kit.
  • Manufacturer
    Sorin Group Usa Inc.

Manufacturer

Sorin Group Usa Inc.