Events

Recall of POLYFIN QR INFUSION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    128467
  • Event Risk Class
    I
  • Event Initiated Date
    2013-06-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Medtronic has become aware of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the connector on medtronic paradigm infusion sets. this recall also provides information on how to prevent this from occurring. exposure of the inside of the tubing connector to fluid is most likely to occur if insulin is spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard after filling the reservoir from a vial of insulin. if this occurs the insulin can temporarily block the vents in the connector that allow the pump to properly prime. if these vents are blocked this can potentially result in too much or too little insulin being delivered which may cause hypoglycemia or hyperglycemia which in extreme cases may cause loss of consciousness or death.

Device

POLYFIN QR INFUSION SET
  • Model / Serial
    Model Catalog: MMT-312L (Lot serial: All lots contact mfg); Model Catalog: MMT-312S (Lot serial: All lots contact mfg); Model Catalog: MMT-318 (Lot serial: All lots contact manf); Model Catalog: MMT-325 (Lot serial: All lots contact manf); Model Catalog: MMT-317 (Lot serial: All lots contact manf); Model Catalog: MMT-324 (Lot serial: All lots contact manf)
  • Product Description
    POLYFIN QR INFUSION SET
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • 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
    HC