Events

Rappel de HeartWare Ventricular Assist System Battery

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-00918-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-09-29
  • 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-00918-1
  • 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 may 2014, heartware distributed field safety notice fsca apr2014 following an increase in reported power management complaints related to earlier than expected battery depletion. information on early battery depletion, identification of potentially faulty batteries, and recommended practices for power management were provided in the field safety notice. heartware is expanding this action to include product code 1650-de. there has been an increase in reported power management complaints related to earlier than expected battery depletion. batteries produced in the ranges bat000001 to bat199999 appear more likely to exhibit premature or unrecognised deterioration of battery capacity.
  • Action
    HeartWare is advising clinicians to continue to use the batteries in accordance with the IFU and Patient Manual. HeartWare will be replacing all affected batteries in January 2016.

Device

HeartWare Ventricular Assist System Battery
  • Modèle / numéro de série
    HeartWare Ventricular Assist System BatteryProduct Codes: 1650, 1650-DE Ranges of Serial Numbers: BAT000001 to BAT199999ARTG 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