Events

Alerte De Sécurité sur PLUM XL ™ family infusion pump, Registration No. 80253310022; Serial Numbers - Attachment

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Hospira Produtos Hospitalares Ltda.; 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
  • ID de l'événement
    1606
  • Date
    2015-06-09
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
    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
    According to the manifestation of the company, no complaints of health problems were identified due to the problem described above. The Spanish language is immediately displayed when the infusion pump is switched on, reading the screen or labeling. If the infusion pump is put into use and the problem is not identified prior to clinical use, attempts by health professionals to program the infusion pump without understanding instructions and other texts on the screen may lead to a programming error incorrect) or a delay in therapy.
  • Cause
    Hospira has identified that some plum xl pumps have been marketed with software, labeling and manual in spanish.
  • Action
    The company that holds the registration in Brazil recommends that the institution notify the professionals about the notification. To correct the problem, Hospira will forward labeling and manual in Portuguese.

Device

PLUM XL ™ family infusion pump, Registration No. 80253310022; Serial Numbers - Attachment

Manufacturer

Hospira Produtos Hospitalares Ltda.; Hospira Inc.
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    ANVSANVISA