Events

Alerte De Sécurité sur Alaris Medley Large Volume Pump Frame Membrane

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

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
    2015-08-28
  • Date de publication de l'événement
    2015-08-25
  • 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_20150828.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: carefusion alaris medley large volume pump frame membrane the united states food and drug administration (fda) has issued a medical device safety alert concerning alaris medley large volume pump (lvp) frame membrane, manufactured by carefusion. the affected devices are identified as follows: frame membrane noem, part number: tc10006587 / 10013801 (lot number 022015502 and 0421151000) frame membrane noem shipped with lvp bezel assembly, part number 49000204 (lot number 031815100, 032415100 and 043015215) manufactured from: february 20, 2015 to april 21, 2015 distributed from: february 25, 2015 to may 8, 2015 the lvp is an infusion pump used to deliver fluids such as nutrients and medications into a patient’s body in controlled amounts. the frame membranes are part of the pump that prevents fluids from leaking into internal components. the supplier in the united states, elite biomedical solutions, discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause patient injury or death. customers were instructed to take the following actions: immediately examine the inventory and quarantine the affected product. the supplier will provide affected facility with a replacement part for each affected frame membrane, along with a label for product return. for details, please refer to the tga website: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm460137.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm460079.Htm if you are in possession of the affected products, please contact your supplier for necessary actions posted on 25 august 2015.

Device

Alaris Medley Large Volume Pump Frame Membrane
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: CareFusion Alaris Medley Large Volume Pump Frame Membrane
  • Manufacturer
    CareFusion

Manufacturer

CareFusion