Events

Alerte De Sécurité sur HeartWare™ Ventricular Assist System

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
    2012-01-04
  • 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_20120104b.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
    Field safety notice: heartware™ ventricular assist system the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers regarding the heartware® controller (product code: 1400) manufactured by heartware, inc. an investigation of a single customer report has confirmed that it is possible in a specific circumstance for medium priority (low flow, high power, and suction) alarm limits to be exceeded without an audible notification or a visible alarm message being displayed on the heartware controller. the reported condition will only occur if the controller has lavare cycle turned on and then, when connected to a monitor, the lavare cycle is turned off during the initial eight seconds of the cycle. there are no reported adverse events or complications associated with the report, and the alarm suppression is not associated with resetting (short-restart) of the hvad pump. a clinical risk to a patient would most likely occur if there were a vad thrombus or occlusion event that caused high watts or low flow. the clinical risk could include failure to provide a warning to the patient that a low flow state existed. such a state would cause symptoms such as hematuria or heart failure to occur and lead the patient to seek medical attention. while death under such circumstance is not likely, low flow ischemia to various organs (e.G. kidneys) could result in reversible impairment that could be corrected by restoring full flow. according to the manufacturer, the affected products have not been distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for further information and necessary actions.

Device

HeartWare™ Ventricular Assist System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: HeartWare® Ventricular Assist System
  • 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