Events

Alerte De Sécurité sur HeartWare Ventricular Assist System Pump Driveline Splice Kit

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
    2015-05-21
  • Date de publication de l'événement
    2015-05-21
  • 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_20150521.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 pump driveline splice kit the united states food and drug administration (fda) has issued a medical device safety alert concerning heartware ventricular assist system (hvad) pump driveline splice kit. the affected devices are identified as follow:- model: 1) hvad pump driveline splice kit; 2) hvad pump driveline splicekit; large od sheath catalogue numbers: 1) asy00116; 2) asy00281 lot numbers: 1) 532770, 567949, 480786, 483769, 490692, 539664, 598189; 2) 654090, 672401, 678800, 690423, 833963, 873159, 880816 according to the manufacturer, excessive force applied will cause failures of the splice repair kit. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1604-2015&w=05202015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 may 2015.

Device

HeartWare Ventricular Assist System Pump Driveline Splice Kit
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: HeartWare Ventricular Assist System Pump Driveline Splice Kit
  • 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