Events

Alerte De Sécurité sur ABBOTT ACCLAIM ENCORE INFUSION PUMPS

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 LABORATÓRIOS ABBOTT PRODUTOS HOSPITALARES.

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
    65
  • Date
    2001-05-14
  • 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
    After an incorrect load of the pump administration package during operator training, the reference pump consistently restricts liquid release. the pump alarm was not sound to alert user of the problem. there were no reports of patient problems, but if the problem was encountered when the pump was connected to a patient who was on critical medication, his or her safety could be at risk.
  • Action
    ECRI RECOMMENDS: (1) DO NOT BUY THE PUMP BECAUSE THERE IS PROBLEM POSITIONING THE PUMP MANAGEMENT ASSEMBLY, WHICH MAY CAUSE PATIENT SAFETY AT RISK. (2) IF YOU HAVE PURCHASED THIS PUMP, YOU MUST RETURN IT TO THE MANUFACTURER, BE REFUNDED OR EXCHANGE FOR ANOTHER MODEL. IF YOU NEED TO CONTINUE TO USE THIS PUMP, ECRI RECOMMENDS THE FOLLOWING: 1. ALERT STAFF IF THERE WAS INCORRECT CHARGING, THE PUMP ADMINISTRATION SET MAY RESTRICT THE RELEASE OF LIQUID OR EVEN FAIL TO RELEASE IT. IN ADDITION, IN THIS OCCASION, THE ALARM MAY NOT WORK TO NOTICE STAFF. 2O. ENSURE THAT ALL YOUR PERSONNEL WILL BE COMPLETELY TRAINED IN INSTALLING THE BOARD OF ADMINISTRATION. 3 MAKE SURE THAT ALL YOUR PERSONNEL ARE TRAINED TO VERIFY THAT THE ADMINISTRATION PIPE ASSEMBLY IS NOT STRETCHED AND THAT IS SECURELY COUPLED IN THE PUMP CHANNEL BEFORE CLOSING THE DOOR. 4 TRAIN YOUR PERSONNEL TO CHECK THE FLOW OF THE DROPS IN THE PUMP ADMINISTRATION CHAMBER, BEFORE

Device

ABBOTT ACCLAIM ENCORE INFUSION PUMPS

Manufacturer

LABORATÓRIOS ABBOTT PRODUTOS HOSPITALARES
  • Source
    ANVSANVISA