Events

Alerte De Sécurité sur Plum A+ Family of Infusers

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
    2013-01-09
  • Date de publication de l'événement
    2013-01-09
  • 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_20130109.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 plum a+ family of infusers the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning plum a+ family of infusers, manufactured by hospira, inc. hospira issued a field safety notice to inform users that the door roller assembly on the plum a+/a+3 infuser family has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the iv administration set’s cassette from the pump. the iv administration set’s cassette contains a flow regulator that is designed to close upon cassette removal to prevent accidental flow. in the event the door roller assembly is broken the regulator closer may not close properly and unrestricted flow and/or over-delivery can occur which has the potential to contribute to life-threatening adverse events. to correct the issue,hospira has redesigned the door roller to improve the strength and reduce the potential for the door roller assembly to break and will arrange a replacement to affected customers for the door rollers. until the door assembly is replaced, the manufactureradvisesthe users to inspect the door roller assembly prior to loading a cassette for signs of damage.If the door roller or axel appears loose, broken, or missing, then the device needs to be taken out of services until the door assembly is replaced with a corrected door assembly. furthermore, hospirarecommendsthe users to keep the cassette door securely closed while the product is not in use to avoid cassette door damage. additionally, to avoid the accidental flow, close the slide clamp or cair roller clamp on the administration set prior to opening the door. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con216883 if you are in possession of the product, please contact your supplier for necessary actions. posted on 9 january 2013.

Device

Plum A+ Family of Infusers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Plum A+ Family of Infusers
  • Manufacturer
    Hospira

Manufacturer

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