Events

Rappel de HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Heartware Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01323-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01323-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Subsequent to a urgent recall for product correction (tga ref: rc-2013-rn-00126-1) of hvad pump's driveline connector housing become partially or fully separated from the front portion of the driveline connector, heartware have identified an alternative failure mechanism. in 8 cases, customers have reported that the locking mechanism of the driveline connector has failed to engage. there have been no reports of injury. heartware has made changes to the manufacturing procedures to address this issue.
  • Action
    Heartware is advising users that should the driveline disconnect from the controller, push the driveline connector back into the controller immediately and contact Heartware for repair.. Heartware is advising clinicians to inspect patient's driveline connector as described in the provided technical bulletin for proper locking. For already implanted patients, please arrange a follow up visit at the earliest convenience to check the patient's driveline connector. If the locking mechanism of the driveline connector is found to have failed to engage, please push the connector back into the controller and contact Heartware for repair.

Device

HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in p...
  • Modèle / numéro de série
    HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)Catalogue Numbers: 1100, 1101, 1102, 1103, 1104 & 1205Serial Numbers: HW001 to HW11215 and HW20001 to HW20296ARTG Number: 181875
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Ltd

Manufacturer

Heartware Pty Ltd
  • 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
    DHTGA