Alerte De Sécurité sur Product Affected by Field Action: SynchroMed II Deployable Infusion Pump (Registration 10339190229) Models 8637-20, 8637-40 - Risk Class IV. DISTRIBUTION MAP IN ANNEX.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par MEDTRONIC COMERCIAL LTDA; MEDTRONIC INC..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1835
  • Date
    2016-02-29
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    According to the company, the customer must "Identify SynchroMed II pumps manufactured prior to project changes through product identification number and expiration date. According to the following information: Product Identification Number for pumps manufactured before design changes: • Model 8637-20: PIN 863702007H • Model 8637-40: PIN 863704007H Any pump with an Expiration Date on or before May 14, 2017 was manufactured prior to design changes. Wait for the Medtronic Representative to contact you for equipment recovery. "
  • Cause
    Medtronic has incorporated enhancements to the synchromed ii pump, which reduces the possibility of an internal short circuit and motor corrosion, resulting in less effective treatment. currently all synchromed ii pumps are already manufactured with these improvements. the statement is intended to inform customers that medtronic representatives will, through each customer's inventory review, retrieve any out-of-use synchromed ii pumps manufactured before design changes with the above improvements.
  • Action
    The company will carry out field corrections. LETTER TO THE CUSTOMERS IN ANNEX. Code FA696.

Manufacturer

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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