Events

Safety Alert for DLP MEDTRONIC AND FEMORAL DLP MEDTRONIC FEMALE DLP MEDTRONIC AND INSERTION KIT. Anvisa registry n ° 10339190179. Models at risk: 57414, 57417, 57421, 96017 and 96021. Affected lots: see Appendix 1 of the Company Alert Message, available at: http://portal.anvisa.gov.br/wps/ wcm / connect / 6e0ea68048e3a8769f349fc758bf9f01 / Letter + to + Customer + - + FA653.pdf? MOD = AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC PERFUSION SYSTEMS; MEDTRONIC COMERCIAL LTDA..

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
    1616
  • Date
    2015-06-26
  • 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
    Medtronic is initiating a voluntary Recall regarding selected models and batches of DLP® Femoral Cannulas and DLP® Femoral Cannulae and Insertion Kits (containing the affected femoral arterial cannula) due to recent reports in which the user presented difficulty or not was able to connect the cannula to the perfusion circuit tube. See Appendix 1 of the alert message for the affected model and batch numbers. The cannula has a drawing with an elevation in the connector region of the connector which assists in both the sliding of the tube over the burrs and ensures that the tube is once placed in place. Research has confirmed that for specific batches of DLP Femoral Artery, the orientation of the connector burrs is to recede. As a consequence there may be delayed or prolonged procedure, trauma to the patient's vasculature or loss of blood (consequences hitherto not recorded in any report involving the product).
  • Reason
    User may have difficulty, or can not, connect the cannula to the perfusion tube.
  • Action
    Medtronic is collecting the batches at risk of the product. To hospitals and healthcare professionals: immediately identify and keep segregated all listed products not used in your inventory. Return the products to Medtronic - the sales representative of the company should assist you in this regard and also with regard to replacement of the product. Check detailed information at http://portal.anvisa.gov.br/wps/wcm/connect/6e0ea68048e3a8769f349fc758bf9f01/Carta+ao+Cliente+-+FA653.pdf?MOD=AJPERES.

Device

DLP MEDTRONIC AND FEMORAL DLP MEDTRONIC FEMALE DLP MEDTRONIC AND INSERTION KIT. Anvisa registry n...

Manufacturer

MEDTRONIC PERFUSION SYSTEMS; MEDTRONIC COMERCIAL LTDA.
  • 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
    ANVSANVISA