Events

Rappel de HeartWare HVAD system

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-2016-RN-00580-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-05-11
  • 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-2016-RN-00580-1
  • 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
    Heartware have received reports of loose power and data connectors on the heartware controller, specifically for loose connector ports within the controller.If a power or data connector becomes loose, controllers could become more vulnerable to water damage, which could lead to internal corrosion, electrical issues, reduced speaker volume and connection failures.In these scenarios, potential risks include:- interruption of circulatory support due to a pump stop, which could cause serious injury or death- reduced ability to detect alarms- loss of communication between the controller and heartware monitor.
  • Action
    HeartWare is advising the clinicians to: 1. Continue to remind the patients currently supported by the HVAD System to follow all instructions in their Patient Manuals including alarm awareness, water avoidance and carefulness when connecting and disconnecting to power and data sources. 2. At the patients’ regularly-schedule appointments, inspect Controllers for loose connectors by gently pressing on each connector and feeling for atypical movement. Do not press hard on the connectors or they could break. If a loose connector is identified, it is recommended that the affected Controller be replaced with a Controller from inventory and contact the local HeartWare representative. If the affected Controller is the patient’s primary Controller, please use discretion as to whether the risks of a Controller exchange outweigh the risks of a Controller with a loose connector. This action has been closed-out on 22/02/2017.

Device

HeartWare HVAD system
  • Modèle / numéro de série
    HeartWare HVAD systemProduct Codes: 1407XXAll HeartWare Controllers affectedARTG 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