Events

Alerte De Sécurité sur Automatic Blood Component Collection System COBE BCT Brand Trima

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 Gambro BCT 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
    182
  • Date
    2000-11-10
  • 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
    Brazil - October 9, 2003. The company GAMBRO DO BRASIL LTDA reported that there are no records in Brazil of gas embolism occurred during donations in the Trima System for Automatic Collection of Blood Components.
  • Cause
    Failure to follow the instructions in the section "preparation for placement of equipment in the donor" of the trima operator's manual in the blood collection systems mentioned may result in air bubble embolism. gambro bct issued a medical equipment alert sent on july 31, 2000, emphasizing the importance of following the instructions for using the collection systems mentioned. gambro bct states that the white tongs on the donor line and the sample collection bag should be closed during preparation for placing the equipment in the donor. failure to close the clamps and leave the line open will cause the bag to collect the sample to fill with air during the test of the equipment and will trigger the pressure test alarm.
  • Action
    Make sure you have received the correspondence sent on July 31, 2000, the Gambro BCT Medical Equipment Safety Alert. Identify any affected product in your inventory. To expel air into the sample bag before connecting it to the donor line, Gambro BCT recommends the following: (1) Open the tong on the donor line and squeeze the sample bag. (2) After expelling air from the sample bag, close both the donor line and the sample bag clamps. Press the CONTINUE button to perform the Tubing SetTest. If the donor line is already connected and note the presence of air in the sample bag: (1) do not open the white tong in the sample bag. (2) Immediately and permanently close the sample bag line by heating seal or metal clip. Discard the bag according to the standard procedure of your institution. (3) Remove the required specimens from the patient's other arm. Gambro BCT declares that the set for placement of the equipment in the donor, or the products collected, will not be compromised if the aforementioned instructions are obeyed. Gambro BCT adds that to prevent future occurrences, the section of the operator's manual, containing the current instructions, will be revised to reinforce the need for verification and removal of air from the sample bag. Gambro BCT will contact your hospital supervisor or blood bank to update your operator's manual and make these changes. For more information, contact your local representative or Gambro BCT directly at 1 (303) 232-6800 in the United States.

Device

Automatic Blood Component Collection System COBE BCT Brand Trima

Manufacturer

Gambro BCT Inc
  • Source
    ANVSANVISA