Events

Safety Alert for HeartWare HVAD Pump Implant Kit

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
    2013-02-19
  • Event Date Posted
    2013-02-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130219.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 hvad pump implant kit the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning heartware hvad pump implant kit. below please see the details of the affected devices: product code: 1100, 1102, 1104, 1205 serial no.: hw001‐hw3827 and hw10000‐hw10675 according to heartware, an investigation of customer complaints has confirmed a small number of events (11 of approximately 2900 implants) where the rear portion of the hvad pump’s driveline connector housing becomes partially separated or fully separated from the front portion of the driveline connector. in the unlikely event of a separation, a repair may be necessary. if left unattended, electrical connection to the controller could be affected and a stop alarm could result. heartware reported that none of the 11 confirmed events resulted in harm to the patients affected. heartware is implementing manufacturing process changes to prevent recurrence of this event. meanwhile, users are advised to inspect the patient’s driveline connector at each routine clinic visit. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con234577 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2013.

Device

HeartWare HVAD Pump Implant Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HeartWare HVAD Pump Implant Kit
  • 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