Alerta De Seguridad para Paradigm Insulin Infusions Sets

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic paradigm insulin infusions sets medical device manufacturer, medtronic inc., has issued a medical device safety alert concerning the paradigm insulin infusion sets [model no.: mmt-317, mmt-318, mmt-324, mmt-325, mmt-312s, mmt-312l, mmt-386, mmt-387, mmt-394, mmt-396, mmt-397, mmt-398, mmt-399, mmt-377, mmt-378, mmt-381, mmt-382, mmt-383, mmt-384, mmt-368, mmt-862, mmt-864, mmt-866, mmt-874, mmt-876, mmt-884, mmt-886, mmt-921, mmt-923, mmt-925, mmt-941, mmt-943, mmt-945, mmt-961, mmt-963, mmt-965, & mmt-975]. the manufacturer 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. exposure of the inside of the tubing connector to fluid is most likely to occur if insulin is spilled on the top of 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. however, the manufacturer has not been aware of any adverse incidents related to aforementioned potential safety issue. the potential for temporary blocking of the infusion set vents can be avoided by not allowing liquid to make contact with the inside of the tubing connector and following the recommended reservoir filling procedure with careful attention to the information provided below: after filling the reservoir, make sure the vial of insulin is held upright when removing the reservoir from the blue transfer guard. this prevents insulin from accidentally getting on the top of the reservoir, which could transfer liquid into the tubing connector. if any liquid (such as insulin, isopropyl alcohol, or water) gets on the top of the reservoir or inside the tubing connector, start over with a new reservoir and infusion set. if the user notice anything unusual during the infusion set prime process such as the insulin continuing to drip from the infusion set cannula when the manual prime has been completed, this may indicate that the connector vents are not working properly. if this occurs, do not insert the infusion set and call immediately for additional assistance. in addition, the manufacturer is also updating the instructions for use to include this information on how to avoid temporary blocking of the infusion set vent membranes due to exposure to fluid. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 jun 2013.



  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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