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 Baxter.

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
    2013-12-13
  • Date de publication de l'événement
    2013-12-13
  • 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_20131213a.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: baxter abacus total parenteral nutrition calculation software medical device manufacturer, baxter, has issued a field safety notice concerning abacus total parenteral nutrition (tpn) calculation software distributed between may 2006 and may 2013 (software versions: 2.0 through 3.0). the possibility exists that a patient could receive another patient’s tpn order due to data corruption. while no patient harm has been reported for this issue, provision of the wrong admixture to patients receiving tpn therapy may cause severe complications, potentially triggering a chain of complications that may lead to a fatal outcome. baxter is requesting users to be consistent with good pharmacy practice, and check the patient order against the final bag label as part of the tpn acceptance procedure to ensure that the patient’s tpn order is correct. furthermore, the tpn order entry software v3.1 upgrades will be arranged. 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 december 2013.

Device

ABACUS Total Parenteral Nutrition Calculation Software
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter ABACUS Total Parenteral Nutrition Calculation Software
  • Manufacturer
    Baxter

Manufacturer

Baxter