Events

Alerta De Seguridad para Abacus Total Parenteral Nutrition Calculation Software

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

¿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
    2012-05-28
  • Fecha de publicación del evento
    2012-05-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120528.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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: baxa abacus total parenteral nutrition calculation software the food and drug administration (fda), united states issued a class i medical device recall concerning abacus total parenteral nutrition (tpn) calculation software [catalogue no: 8300-0045: abacus calculator only (abacus ce); 8300-0046: abacus single work station (abacus se); 8300-0047: abacus multi-work station (abacus me)] manufactured by baxa corporation. according to the fda, the abacus tpn calculating software is an fda class i laboratory information management system windows-based program used in ordering total parenteral nutrition. according to the manufacturer, a number of errors have been reported by abacus software users as a result of ordering salt based parenteral nutrition ingredients on an ion based ordering template. abacus tpn calculation software is designed and intended to allow the ordering of electrolytes in only one of two ways: as a salt (such as calcium gluconate 10%) or as an elemental ion (such as calcium). however, if a dosage is entered into the system based on one method, when the template is configured for the other method, a dosing error can occur. the problem associated with mix-ups related to salt-based or ion-based ordering of electrolytes is not exclusive to calcium gluconate. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm305744.Htm according to the local supplier, the affected device was not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 28 may 2012.

Device

Abacus Total Parenteral Nutrition Calculation Software

Manufacturer

Baxa Corporation