Events

Safety Alert for HeartWare Ventricular Assist System, Controller

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by HeartWare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-05-20
  • Event Date Posted
    2013-05-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130520a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: heartware ventricular assist system, controller the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning heartware controller, component of a ventricular assist device. the affected product codes are 1400 and 1401au. all serial numbers are affected. heartware has advised of a recent incident involving a patient death thirty-four months post heartware ventricular assist system implantation. the patient was found alone and unresponsive with the controller alarming approximately three hours post event. log file analysis confirmed that the pump had stopped. 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 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 commutation in which the motor control software was no longer driving the pump’s motor controller circuit and leading to a pump stop. physicians are reminded of the following: be aware of electrostatic discharge 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 left ventricular assist device 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. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00438-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 may 2013.

Device

HeartWare Ventricular Assist System, Controller
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HeartWare Ventricular Assist System, Controller
  • Manufacturer
    HeartWare

Manufacturer

HeartWare
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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
    DH