Events

Field Safety Notices about Formula® Hemodialysis Machines

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 Medtronic.

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
  • 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
    To date, three thermal events that led to fire have been reported in three separate machines; one during a disinfection cycle, and two prior to patient use when the machines were switched on. while there was damage to each of these machines, no patients or healthcare providers were injured as a result of these events. the occurrence of such events is low, with a rate of approximately 0.01% of formula machines manufactured since 1998. based on our internal investigations, we determined the battery charge board to be the source of two of the events. the source of the third event could not be conclusively confirmed due to the extent of the damage to the board, but the available evidence is consistent with the other two events. we have determined that disconnecting the battery charge board will eliminate the possibility of the failure mode while a permanent solution is implemented. .

Device

Formula® Hemodialysis Machines
  • Model / Serial
    Formula®, Formula® 2000, Formula® PLUS, Formula® 2000 PLUS, Formula® Therapy, and Formula® Domus.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    AMPMDRS