Events

Alerte De Sécurité sur Infusomat Space Set Air IL (Non-photosensitive equipment for infusion of parenteral solutions into infusion pumps) - Code 441702 - Registration 80136990755 - Lots 15G21LA335, 15H21LA383, 15H21LA384, lSH24LA385 and 15H31lA398 and Enteral Nutrition Equipment for infusion pumps B.Braun (Infusomat Space Set Enteral Air) Code 402111 - Registration number 80136990733, lot 15H2SLA388

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 B. Braun S.A..

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
    1697
  • Date
    2015-10-09
  • 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.
  • Notes supplémentaires dans les données
    According to the manifestation of the company, this condition can compromise the correct functioning during the removal of the pump equipment, which can result in free flow, in case the health professional does not perform the standard procedure, which consists of closing the clamp and disconnect the patient's equipment before removing it from the pump.
  • Cause
    During an inspection by the production supervisor (assembly area), the erroneous assembly of the green infusomat clamp component was identified by a specific employee. although the employee was trained, he was assembling the tongs inverted. 100% of the employee's production was inspected and the problem was confirmed.
  • Action
    The company is carrying out the collection of the lots mentioned in this alert and requests the interruption of the use of said batches, the segregation thereof, as well as the information to the B. Braun SA laboratories of the quantities of existing units of each batch number for the process of recollection

Device

Infusomat Space Set Air IL (Non-photosensitive equipment for infusion of parenteral solutions int...

Manufacturer

Laboratórios B. Braun S.A.