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 Limited.

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-00126-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-08
  • 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-00126-1
  • 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
    There is potential for the rear portion of the hvad pump's driveline connector housing partially or fully separating from the front portion of the driveline connector. if unattended, the electrical connection to the controller could be affected and loss of mechanical circulatory support may occur.
  • Action
    HeartWare are advising medical practitioners to inspect the patients drive line connector at each routine clinic visit. If the rear portion of the driveline connector housing is partially separated from the front portion, hand tighten the front and rear portions together. Contact your HeartWare Representative to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer. If the driveline connector housing is completely separated secure the driveline connector housing to the controller with a splint to maintain a secure connection until a repair can occur. Where the connector/controller connection is secured by splinting the controller and connector with tongue depressors and electrical tape. Contact your HeartWare Representative to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer. Further information can be found ont he TAG website at https://www.tga.gov.au/alert/heartware-ventricular-assist-system

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)Product Code: 1100, 1101, 1102, 1104, 1205Serial Numbers: HW001 to HW3827 and HW10000 to HW10675ARTG Number: 181875
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Limited

Manufacturer

Heartware Pty Limited
  • 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