Events

Alerte De Sécurité sur CARDIOMEMS HF 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 St Jude Medical 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
    I1610-410
  • Numéro de l'événement
    2015DM-0013476
  • Date
    2016-10-04
  • 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=119
  • 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 states that it has detected that if the user turns off the system incorrectly they may show an inability to turn on again, leading to delays and possible adverse events on the patients.

Device

CARDIOMEMS HF System
  • Modèle / numéro de série
    CM3000, CM1000 and CM1010
  • Description du dispositif
    The CARDIOMEMS HF system is indicated for the wireless measurement and monitoring of pulmonary artery pressure in patients with heart failure NYHA (NEWYORK HEART ASSOCIATION) class III who have been hospitalized for heart failure during the previous year. The hemodynamic data allow doctors to treat heart failure and reduce hospitalizations for this condition. The doctor can use the CARARDOMS HF system in the hospital or the office to perform pulmonary blood pressure measurements and analyze them. The patient can use the CARDIOMEMS HF system in his home to make and send hemodynamic measurements and pulmonary arterial depression wirelessly to a secure database for analysis and evaluation by the physician.
  • Manufacturer
    St Jude Medical Inc

Manufacturer

St Jude Medical Inc
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA