Events

Alerte De Sécurité sur HeartWare HVAD Systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par HeartWare.

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
  • Date
    2018-05-04
  • Date de publication de l'événement
    2018-05-04
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180504.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: medtronic heartware hvad systems medical device manufacturer, heartware (now a part of medtronic), has issued a medical device safety alert concerning its hvad systems. the affected devices are identified as the following: - controller/ controller kits (model number: 1400, 1401, 1403, 1407, 1420; all serial numbers) dc adapter (model number: 1435, 1440; all serial numbers) ac adapter (model number: 1425, 1430; all serial numbers) battery pack (model number: 1650; all serial numbers) the manufacturer informs healthcare professionals of the potential for a transient interruption of the electrical connection between an hvad system power source (battery, ac adapter, or dc adapter) and the hvad controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones ("beeping"). this interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller's power source socket, and typically lasts 1-2 seconds. unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or acidc connectivity at the time of the audible tone. a critical battery alarm may also be momentarily displayed due to this phenomenon. according to the manufacturer, the projected occurrence rate of unexpected power source switching with the hvad system over a 2-year period on a per patient basis is approximately 25%. approximately 97% of reported occurrences of this issue resulted in no patient symptoms. however, the potential harm associated with transient power source interruptions can vary, depending on whether two power sources are connected (as instructed in the instructions for use and patient manual) versus a single source, and the patient's underlying health. the per patient probability of serious adverse events due to this issue is approximately 0.003. the manufacturer has continued to develop and implement enhancements into the hvad system to improve power source connectivity and reduce the potential for unintended power source switching. affected users should follow the manufacturer’s recommendations for effective power source management of the hvad systems. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 may2018.

Device

HeartWare HVAD Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic HeartWare HVAD Systems
  • Manufacturer
    HeartWare

Manufacturer

HeartWare
  • 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
    DH