Events

Alerte De Sécurité sur INFUSION PUMP LIFECARE PLUM A + (Registro Anvisa: 80253310023).

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..

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
    1051
  • Date
    2011-03-11
  • 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 record holder, the problem is related to improper mounting of the buzzer on one of the electronic boards of the pumps. The problem was identified through reports of alarm failure reported by users of the pumps, sent globally to the company. Hospira identified an incidence less than 1 (one) reported failure per million infusions, based on these reports.
  • Cause
    Possibility of failure of the sound alarm of the equipment.
  • Action
    The registry holder has informed that it will communicate to clients a sound alarm test methodology, to verify the problem. The solution to the problem is still being developed by the company. If you have this infusion pump in your inventory and you have verified problems with this product, or if you want to clarify your doubts with Hospira Produtos Hospitalares Ltda., Use the phone number 0800-7733-133.

Device

INFUSION PUMP LIFECARE PLUM A + (Registro Anvisa: 80253310023).

Manufacturer

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