Events

Safety Alert for HeartWare HVAD Pumps

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

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
    2016-08-12
  • Event Date Posted
    2016-08-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_201608012b.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 pumps medical device manufacturer, heartware incorporation, has issued a medical device safety alert concerning its hvad pumps. the affected devices are identified as follows:- model number: 1104gb serial number: sterile, un-implanted stock in inventory with serial numbers prior to hw25838 the manufacturer has reviewed certain complaints related to the hvad system and announced a voluntary recall of specified implant kits (pumps) in hospital inventory, which may be more susceptible to electrical faults if the driveline becomes contaminated. according to the manufacturer, contamination of the driveline-to-controller connector can occur during the implant procedure or post operatively from fluid ingress into the driveline. connector contamination of the driveline has been seen to occur most often in the first 30 days post implant. affected devices that have already been implanted into a patient are not subject for removal. the presence of fluid or foreign material at the driveline/controller connector may impact the function of the pump and controller. specifically, foreign material at the driveline/controller connector could lead to electrical faults 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. the manufacturer has implemented manufacturing process improvements designed to prevent driveline connector contamination in new implant kits. users are advised not to attempt to repair or service any components of the heartware system. if the heartware system equipment malfunctions, they should promptly contact their local representative. according to the local supplier, the affected serial numbers are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 august 2016.

Device

HeartWare HVAD Pumps
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HeartWare HVAD Pumps
  • Manufacturer
    HeartWare Incorporation

Manufacturer

HeartWare Incorporation
  • 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