Events

Safety Alert for SynchroMed II Implantable Drug Infusion Pump

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

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
    2014-03-18
  • Event Date Posted
    2014-03-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140318a.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 synchromed ii implantable drug infusion pump medical device manufacturer, medtronic, has issued a field safety notice concerning synchromed ii implantable drug infusion pump. the manufacturer detected an upward shift in reports of occurrence for overinfusion, which is defined as an infusion rate exceeding the programmed infusion rate by more than 14.5% as described in the labeling. when overinfusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn from the pump is less than the volume expected. the cause for pump malfunction leading to overinfusion remains under investigation and has not been linked to any specific pump lot, drug used, or geographical area. the manufacturer is not recommending prophylactic replacement of pumps. users are advised to always follow pump refill instructions per the device labeling to allow detection of an overinfusing pump. the manufacturer advises users to inform them if overinfusion is strongly suspected and return any explanted products to the manufacturer for mechanical and functional analysis. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 march 2014.

Device

SynchroMed II Implantable Drug Infusion Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic SynchroMed II Implantable Drug Infusion Pump
  • 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
    DH