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 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-00438-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-05-15
  • 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-00438-1
  • 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 has advised of a recent incident involving a patient death thirty-four months post heartware ventricular assist system implantation. functional testing of the returned controller showed that the device (including motor control circuits) performed all functions as intended within specification and with no fault alarms or errors. the exact cause of the event cannot be conclusively determined; however, heartware suspects that an electrostatic discharge (esd) through the exposed controller power ports during battery replacement caused or contributed to data corruption in the pump motor controller resulting in a loss of communication in which the motor control software was no longer driving the pump’s motor controller circuit and leading to a pump stop.
  • Action
    Physicians are advised of the following: -Be aware of Electrostatic Discharge (ESD) and its potential to cause disruptive and possibly fatal faults to susceptible patients. -Avoid devices and conditions that may induce strong static discharges (for example, television or computer monitor screens) as electrostatic discharges can damage the electrical parts of the system and cause the LVAD to perform improperly or stop. -Always have a backup controller handy and a care giver nearby when changing power sources or controllers. Be watchful for unusual changes in power or flow alarms for a period of time following equipment change.

Device

HeartWare Controller (Ventricular assist device)
  • Modèle / numéro de série
    HeartWare Controller (Ventricular assist device)Product code: 1400, 1401AUAll serial numbers are affectedARTG 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