Events

Avis De Sécurité sur HeartMate ll® System Controller, Model 105109

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Abbott Laboratories.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-03-29
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    As follow-up to our most recent communication in september, 2015, we are advising you that thoratec corporation, an abbott laboratories company, is updating its alert guides, conducting a software upgrade and adding controller alignment markings for the heartmate ii® system controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations. a number of training and education improvements were completed in 2014 upon a voluntary field correction regarding the patient controller exchange process. as a result, we saw an 80% reduction in adverse event rates for system controller exchanges, and a 90% shift of system controllers being exchanged at home to being completed in the hospital, which is consistent with the instructions for use. despite this, patients continue to experience a very low level of adverse events (including serious injury or death), at a rate of o. 1%, as a result of unnecessary patient controller exchanges. system controller exchanges are best conducted by medical professionals in a controlled environment. .

Device

HeartMate ll® System Controller, Model 105109

Manufacturer

Abbott Laboratories
  • 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
    AMPMDRS