Events

Rappel de HeartWare Controller (Ventricular assist device)

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-2015-RN-00001-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-07
  • 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-2015-RN-00001-1
  • 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
    In 2013, heartware advised clinicians (tga reference: rc-2013-rn-00438-1) on measures to take in relation to patient safety risks associated with electrostatic discharge (esd) following two incidents of patient deaths where the electrostatic discharge (esd) was suspected to cause or contribute to data corruption in the pump motor controller resulting in a loss of commutation.The risk of injury associated with esd includes the interruption of circulatory support due to a pump stop. since the 2013 field safety corrective action, heartware have received reports of one additional death and one additional serious injury in which esd may have caused or contributed to data corruption in older controllers resulting in the loss of commutation to pump motors, which ultimately led to pump stops. the affected controllers exhibit a higher susceptibility to esd than newer controllers.
  • Action
    Clinicians are requested to inspect inventory and quarantine all affected controllers. For patients who possess affected Controllers (both primary and backup) Clinicians are advised as follows: (a). For Primary Controllers: Review the applicable risks and if medically advisable, exchange the affected Controller under medical supervision with a new Controller (serial number CON005473 or higher). (b). For Backup Controllers: Contact the patient and arrange to have the backup Controller replaced with a new Controller (serial number CON005473 or higher). A HeartWare representative will contact the clinicians to assist with this process and to help replace affected Controllers where necessary. This action has been closed-out on 14/07/2016.

Device

HeartWare Controller (Ventricular assist device)
  • Modèle / numéro de série
    HeartWare Controller (Ventricular assist device)Product Codes:1400, 1401XXRange of Serial Numbers: CON000001 through CON005472ARTG 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