Events

Alerte De Sécurité sur MedSystem III Infusion Pump

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 ALARIS Medical Systems 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
    366
  • Date
    2001-12-30
  • 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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    A hospital member of ecri reported that the low dosage can only be programmed within the pump calculator is 0.1mcg / kg / min; however, some of these drugs used (eg, fenoldopam, isoproterenol, norepinephrine) have a dosage range below 0.1 mcg / kg / min.
  • Action
    For most infusions, the drug dose calculator on the MedSystem III infusion pump has sufficient resolution; however, for doses below 0.1 mcg / kg / 1min, the calculator should not be used. In these cases, the clinician should use another calculator with sufficient resolution and then place the correct measurement on the pump. In cases where these calculations must be done regularly an appropriate backup calculator should be well on hand. In addition, whenever a user does the calculation manually, another team member should confirm them before programming the pump. For more information, contact ANVISA's Technovigilance Unit, by phone at (61) 448-1485. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

MedSystem III Infusion Pump

Manufacturer

ALARIS Medical Systems Inc
  • Source
    ANVSANVISA