Events

Safety Alert for CircuLite SYNERGY Circulatory Support System

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

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
    2013-08-07
  • Event Date Posted
    2013-08-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130807a.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: circulite synergy circulatory support system the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning synergy circulatory support system, manufactured by circulite gmbh. the affected device is synergy micro-pump kit sik 100 (note: this kit is also part of the synergy implantation kit sik 001). according to the alert, circulite is now evaluating the root causes of inflow cannula fracture after receiving three relevant reports. effective immediately, circulite is suspending implants of the surgical synergy circulatory support system in europe until further notice. the manufacturer provides the following advice to the affected users: physicians are advised to suspend implant of the synergy system in new patients. physicians are advised to inform patients of this safety alert. patients currently on device should be monitored as usual for any signs of low flow through the pump in the absence of a decrease in speed setting during routine follow-up exams (e.G., decreased current, hemolysis). if low flow is suspected, obtain a chest x-ray and/or ct scan to evaluate the inflow cannula position and integrity. if a cannula fracture is suspected, the pump should be stopped under medical supervision and a decision made as to whether or not to explant the pump. a decision should be made as to whether the patient requires support with another form of mechanical circulatory support or can be managed medically. if the pump is explanted, blood should be aspirated from the inflow cannula and outflow graft to extract any thrombus that may have formed during the period of pump stop. the outflow graft can be ligated near its insertion with the subclavian artery. the inflow cannula can be occluded using a vascular occlusion device. as usual, patients should be instructed to return to the hospital for controller alarms or if they exhibit signs of hemolysis such as red tinged or dark colored urine. existing patients will continue to be supported. at this time, devices that are serving as backup for patients who were previously implanted may be retained. unnecessary devices should be returned to the manufacturer. immediately inform circulite if any abnormalities in the pump or patient are observed. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con297539 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 august 2013.

Device

CircuLite SYNERGY Circulatory Support System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: CircuLite SYNERGY Circulatory Support System
  • Manufacturer
    CircuLite GmbH

Manufacturer

CircuLite GmbH
  • 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