Events

Field Safety Notices about HeartMate II® System Controller

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Thoratec.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-09-14
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Thoratec is issuing this urgent field safety notice to remind all hospitals to carefully monitor the expiration date of the 11v lithium-ion backup battery (“backup battery”) in the heartmate ii lvas system controller. failure to do so can result in preventable backup battery advisory alarms and unwarranted system controller exchanges by patients. thoratec has received reports of two patient deaths and one serious injury associated with patients attempting to exchange system controllers in response to these alarms. thoratec’s investigations of the reports have not revealed any failure of the devices to meet specifications or deficiencies in quality control procedures that would have caused the backup battery advisory alarms.

Device

HeartMate II® System Controller
  • Model / Serial
    106016, 106017, 106762, 106015, 107801
  • Manufacturer
    Thoratec

Manufacturer

Thoratec
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AMPMDRS