Events

Alerte De Sécurité sur 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
    2013-03-22
  • Date de publication de l'événement
    2013-03-22
  • 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_20130322.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 infusion pumps it comes to our attention that the notified body national standards authority of ireland (nsai) has suspended the quality management systems certificates (iso 13485) for hospira’s manufacturing facilities in lake forest and costa rica with effect from 28 february 2013. the health canada and the medicines and healthcare products regulatory agency (mhra), united kingdom had posted safety alerts on their website to inform the public of the issue and the current actions taken by the manufacturer. details could be found at the following websites: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/25869a-eng.Php http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/26209a-eng.Php http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con244550 according to hospira, all new infusion pumps are being held globally under quarantine status, and no new pumps are to be placed on the market until the certificate suspension is lifted. however, the infusion pumps in fields are still to be serviced, maintained and repaired. healthcare professionals are advised to weight the risk/ benefit to patients associated with the use of the device when administering critical therapies. customers are advised to consider the use of an alternative pump, particularly in patients in which a delay/ interruption of therapy could result in serious injury and death. in hong kong, the following hospira infusion pumps are listed under the medical device administrative control system (mdacs): infusion pump, plum a+ (hkmd no.: 100165) plum a+3 infusion pumps (hkmd no.: 100395) plum xld (hkmd no.: 110133) gemstar infusion pump (hkmd no.: 110474) in view of the failure in complying with the mdacs requirements, the above products were temporarily delisted with immediate effect. the status of this temporary delisting will be reviewed 3 months later from today. posted on 22 march 2013.

Device

Infusion Pumps
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Infusion Pumps
  • Manufacturer
    Hospira

Manufacturer

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