Events

Alerte De Sécurité sur Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps

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.

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
    2014-05-05
  • Date de publication de l'événement
    2014-05-05
  • 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_20140505.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: abbott acclaim infusion pumps and hospira acclaim encore infusion pumps the united states food and drug administration (fda) has issued a medical device safety alert concerning abbott acclaim infusion pumps and hospira acclaim encore infusion pumps, manufactured by hospira, inc. the affected abbott acclaim infusion pumps, list number 12032, were manufactured from february 1998 to november 1998 and distributed from september 1998 through february 2004. the affected hospira acclaim encore infusion pump, list number 12237, were manufactured from february 1997 to february 2010 and distributed from july 1999 through november 2013. the manufacturer has received customer reports of broken door assemblies on the abbott acclaim infusion pumps and the hospira acclaim encore infusion pumps. when the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. if the door assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. if the door cannot be closed, the pump cannot be used which can result in a delay of therapy. use of these affected products may cause serious adverse health consequences, including death. the manufacturer recommends users to inspect each hospira/abbott acclaim encore infusion pump for door handle cracks, prior to programming a therapy, by following the steps mentioned in the alert. after following the instructions, if the user determines that a pump has a door that does not close correctly or if free flow is detected while the administration set is in the pump with the door closed, the user should close the roller clamp, remove the pump from clinical service and contact the manufacturer. for details, please refer to the following fda websites: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm395845.Htm http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm395854.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 5 may 2014.

Device

Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps

Manufacturer

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