Events

Safety Alert for arterial filter affinity

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Perfusion Systems || Medtronic México S.R.L de Cv.

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
    I1611-536
  • Event Number
    2010DM-0004625-R1
  • Date
    2016-11-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=112
  • 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

Device

arterial filter affinity
  • Model / Serial
    BB841, specific lots.
  • Product Description
    Description: AFFINITY arterial blood filters are sterile, non-pyrogenic devices for single use and are designed to filter micro-symbols of the largest size circuit in microns specified, for periods of up to 6 hours during cardiopulmonary bypass surgery. Use: these filters are indicated for use in all cardiopulmonary bypass procedures for the removal of particles and gaseous micro piston. The filters are single-use, sterile, non-pyrogenic devices designed to filter micro-plots larger than the specified micron size from the circuit of periods of up to six hours during cardiopulmonary bypass surgery. AFFINITY351 / cb351 arterial filter (38μ, 351 / cb351 arterial blood filter (20μ arterial blood filter) AFFFITY arterial blood filters are sterile, non-pyrogenic devices for single use and are designed to filter microcircuits of the circuit greater than the specified micron size, for periods of up to 6 hours during cardiopulmonary bypass surgery AFFINITY arterial blood filters carmeda (cb351 and cb 353) are coated with an impermeable bioactive surface (heparin), which provides blood contact surfaces resistant to thrombus formation TRILLIUM AFFINITRY NT 541t: the membrane oxygenator with integrated CVR AFFINITY NT (plasma-resistant defibra oxygenator (PRF) with bioactive surface TRILLIUM is designed to be used in an extracorporeal perfusion circuit to collect venous blood and blood-pitched cardiotomy, to heat or cool the blood, and to oxygenate and eliminate the dioxide blood carbon during systemic cardiopulmonary bypass procedures for up to 6 hours.
  • Manufacturer
    Medtronic Perfusion Systems || Medtronic México S.R.L de Cv

Manufacturer

Medtronic Perfusion Systems || Medtronic México S.R.L de Cv
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA