Events

Alerte De Sécurité sur PLUM LifeCare 5000 Series and PLUM XL Families 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 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
    2013-12-12
  • Date de publication de l'événement
    2013-12-13
  • 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_20131212.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: hospiraplum lifecare 5000 series and plum xl families of infusers the australia therapeutic goods administration (tga) posted a medical device safety alert concerning plum lifecare 5000 series and plum xl families of infusers manufactured by hospira inc.The affected products are identified as follows:- plum lifecare 5000, list number: 02507 plum xl, list number :11555 plum xlm, list number: 11846 plum xld, list number: 11859 the door roller assembly on the plum a lifecare 5000 series and plum xl 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 manufacturer is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette: open the cassette door by pulling on the lever; unlatch the cassette door by pushing on the door release tab and pulling the door down; visually inspect the door roller pin for any evidence of the damage or door roller misalignment; and ensure that the door roller spins smoothly with a finger touch. if any door rollers or pins appear loose, broken or missing, hospira advises users to remove the device from use. the manufacturer is in the process of retiring the plum lifecare 5000 and plum xl in 2015. for details, please visit the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01288-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 december 2013.

Device

PLUM LifeCare 5000 Series and PLUM XL Families of Infusers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: HospiraPLUM LifeCare 5000 Series and PLUM XL Families of Infusers
  • Manufacturer
    Hospira Inc

Manufacturer

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