Events

Safety Alert for HeartWare™ Ventricular Assist System

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
    2012-01-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120104b.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
    Field safety notice: heartware™ ventricular assist system the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers regarding the heartware® controller (product code: 1400) manufactured by heartware, inc. an investigation of a single customer report has confirmed that it is possible in a specific circumstance for medium priority (low flow, high power, and suction) alarm limits to be exceeded without an audible notification or a visible alarm message being displayed on the heartware controller. the reported condition will only occur if the controller has lavare cycle turned on and then, when connected to a monitor, the lavare cycle is turned off during the initial eight seconds of the cycle. there are no reported adverse events or complications associated with the report, and the alarm suppression is not associated with resetting (short-restart) of the hvad pump. a clinical risk to a patient would most likely occur if there were a vad thrombus or occlusion event that caused high watts or low flow. the clinical risk could include failure to provide a warning to the patient that a low flow state existed. such a state would cause symptoms such as hematuria or heart failure to occur and lead the patient to seek medical attention. while death under such circumstance is not likely, low flow ischemia to various organs (e.G. kidneys) could result in reversible impairment that could be corrected by restoring full flow. according to the manufacturer, the affected products have not been distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for further information and necessary actions.

Device

HeartWare™ Ventricular Assist System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HeartWare® Ventricular Assist System
  • 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