Events

Alerta De Seguridad para MedNet Medication Management Suite

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

¿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
    2017-10-25
  • Fecha de publicación del evento
    2017-10-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171025.html
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: hospira mednet medication management suite the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning hospira labelled mednet medication management suite – with plum 360 infusion system [(i) version 6.1; list number: 16037-75-01; (ii) version 6.21; list number: 16037-75-02], manufactured by hospira (now icu medical). the manufacturer has identified issues with hospira labelled mednet medication management suite versions 6.1 and 6.21 when used with plum 360 drug library management that occur during an import of a plum 360 drug library. the mednet meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. this includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. a change to a piggyback rule set could result in a delay initiating a therapy or interruption of an active infusion. this issue could also lead to mixing of two infusion solutions. if two mixed solutions are incompatible a particulate could result or, if during a transfusion, a blood clot could form in the administration set. in rare circumstances, these conditions could lead to serious adverse health consequences. the manufacturer is advising users that the issue arises during an import of a plum 360 drug library. users who have performed an import of a plum 360 drug library or have the need to do so should refer to the information provided to customers to confirm if the drug library is affected during the import. a correction to the issues will be addressed in mednet version 6.3. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-01336-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 october 2017.

Device

MedNet Medication Management Suite
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hospira MedNet Medication Management Suite
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DH