Events

Rappel de PARADIGM 554 INSULIN PUMP

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    84913
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic is communicating to paradigm pump users health care professionals and the certified pump trainers about the following three issues and proactively inform customers on how to avoid and mitigate these issues. 1.Users having experienced issues with the drive support cap of the pump: the insulin pump's drive support cap holds the pump motor in place and allows the motor's piston to press against the reservoir to deliver insulin. some users have experienced a loose drive support cap and in rare cases the cap may protrude from the bottom of the reservoir compartment. 2.Potential pump damage due to accidental exposure to water: as explained in the pump user guide exposure to water may result in pump alarm damage of the pump's internal electronics or cause the buttons to stop working. although it is unlikely that water damage will occur if an insulin pump is splashed or briefly dunked it should not be immersed in water. 3.Sensor graph timeout on the veo insulin pumps only: this information applies only to paradigm veo (mmt-554 and mmt-754) pump users who are also using medtronic continuous glucose monitoring and have the low glucose suspend feature enabled. the factory default setting for sensor graph timeout is set to 2 minutes. if the sensor graph timeout is set to "none" it can prevent the auto-resume of basal delivery 2-hours after a low glucose suspend event which can result in elevated blood glucose values. this will only happen if the pump user goes to the sensor graph screen during a low glucose suspend event and leaves that screen displayed.

Device

PARADIGM 554 INSULIN PUMP
  • Modèle / numéro de série
    Model Catalog: MMT-554 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-722 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-754 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-522 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-511 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-715 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-515 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-712 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: MMT-512 (Lot serial: > 10 lot numbers contact mfg)
  • Description du dispositif
    PARADIGM 554 INSULIN PUMP
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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