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
    2015-06-17
  • Date de publication de l'événement
    2015-06-17
  • 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_20150617.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: heartware ventricular assist system the united states food and drug administration (fda) has issued medical device safety alerts concerning heartware ventricular assist system (vas), manufactured by heartware. the affected devices are identified as follow:- product codes: 1101, 1103 serial numbers: all heartware systems currently in use manufacturing and distribution dates: january 2008 to march 2015 the alignment guides in the power supply connector ports may wear down over time. this can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their vas. an interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. the company has reported 33 reports of malfunction and one serious injury related to this problem. the manufacturer sent their customers an urgent medical device correction notice on may 25, 2015 to alert them of the problem and actions to take. the manufacturer will replace all defective controllers by the end of june 2016. the manufacturer is reminding patients to use the device safely: never disconnect from both power sources at the same time. take care when connecting to power sources. keep the outer sheath of the driveline protected from excessive sunlight. beware of accidental snagging or pulling of the driveline. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm451456.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm451447.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 june 2015.

Device

HeartWare Ventricular Assist System
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • 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