Events

Alerte De Sécurité sur TRELLIS Peripheral Infusion System

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par COVIDIEN IIC || EV3 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
    R1502-74
  • Numéro de l'événement
    2014DM-0012263
  • Date
    2015-02-18
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer reports that a manufacturing error caused balloon inflation ports to be mislabeled, which may cause the physician using the device to inflate balloons in the wrong order, causing potential formation of blood clots that may be dislodged and mobilized within of the lungs, leading to the generation of possible adverse events on the patient.

Device

TRELLIS Peripheral Infusion System
  • Modèle / numéro de série
    TRELLIS 6 and TRELLIS 8, models BVT608010, BVT608030, BVT612010, BVT612030, CVT808015, CVT808025, || CVT812015, CVT812025, EVT808015, EVT808025, || EVT812015V01 and EVT812025V01, specific lots
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    The TRELLIS peripheral infusion system is designed for the controlled and selective infusion of liquids, includingtrolyolitics, inside the peripheral vasculature.
  • Manufacturer
    COVIDIEN IIC || EV3 INC

Manufacturer

COVIDIEN IIC || EV3 INC
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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
    NIDFSINVIMA