Events

Safety Alert for HeartWare HVAD System Controller/ Controller Kits

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
    2018-08-31
  • Event Date Posted
    2018-08-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180831.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: medtronic heartware hvad system controller/ controller kits medical device manufacturer, heartware (a part of medtronic), has issued a medical device safety alert concerning its heartware hvad system controller/ controller kits [model numbers: 1403, 1407, 1420; serial number range: con300175 – con320540]. the manufacturer has become aware that the controller units in the range mentioned above may not meet the labeled standard for protection against water or fluid ingress. some units have the potential to develop hairline cracks at the power ports of the controller housing. the cracks may allow for water or fluid ingress if the patient does not follow the instructions for use and the patient manual, including use of a water-resistant shower bag to help protect the unit. this can lead to varying degrees of controller malfunction, including pump stop. according to the manufacturer, the cracks were found during manufacturer inspection of product under 10 x magnifications and are not visible without magnification. the root cause was determined to be a latent interaction between the materials used in the housing unit and the nitrile rubber gasket of the power port connector. the manufacturer recommends the following patient manual instructions should be reinforced: patients currently supported by the hvad system should follow all instructions in their patient manuals regarding water or fluid avoidance, which remain unchanged, and understand the importance of always using a shower bag when showering. if a patient encounters a situation in which their hvad system controller is exposed to water or fluid outside of conditions described in the ifu and patient manual, the patient should be advised to contact his/her vad coordinator. if further assistance is needed, clinicians should contact their local supplier. the manufacturer and the independent practitioner quality panel do not recommend proactive controller exchanges as a result of this potential issue. the manufacturer has since resolved this issue in the manufacturing process, and all newly distributed controller units are no longer susceptible to this materials interaction. no other hvad system components are susceptible to the issue. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 august 2018.

Device

HeartWare HVAD System Controller/ Controller Kits
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic HeartWare HVAD System Controller/ Controller Kits
  • 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