Events

Alerte De Sécurité sur Gemstar Docking Station

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

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
    2013-11-05
  • Date de publication de l'événement
    2013-11-05
  • 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_20131105a.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: hospira gemstar docking station the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning gemstar docking station (list numbers 13075-xx-07, 13075-xx-09) manufactured by hospira inc. two problems may occur when the above gemstar docking station is used with gemstar pumps and external battery pack. first, when the docking station is used with a gemstar phase 3 infusion pump (list numbers 13000-xx, 13100-xx or 13150-xx) the pump may fail to power up while connected to the docking station. second, when the docking station is used with a gemstar phase 4 infusion pump (list numbers 13086-xx, 13087-xx or 13088-xx) and an external battery pack (list number 13073-xx) the pump may display error code 11/003 indicating excessive input voltage from the external sources. the 11/003 error code will stop infusion if it occurs while an infusion is in progress. as a delay of therapy may occur which can result in patient injuries, hospira advises users to: use two fresh internal aa batteries if a failure to power up occurs. remove the battery pack prior to installing the pump into the docking station in order to mitigate the potential for an 11/003 error code. report to hospira if their pumps experience a failure to power up or an 11/003 error code. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 november 2013.

Device

Gemstar Docking Station

Manufacturer

Hospira Inc
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DH