Events

Alerte De Sécurité sur Abacus Total Parenteral Nutrition Calculation Software

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Baxa Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-05-28
  • Date de publication de l'événement
    2012-05-28
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120528.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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