Events

Alerte De Sécurité sur PRESSURE REGULATOR FOR OMRIX APPLICATION DEVICE - Registration 80145909027 - QPR6: MRXQ0053; MRXQ0054; MRXQ0057; MRXQ0063; MRXQ0065; MRXQ0066; MRXQ0067; MRXQ0070; MRXQ0599; MRXQ1059; MRXQ1060; MRXQ1061 ;. MRXQ1062; MRXQ1063; MRXQ1069; MRXQ1072; MRXQ1073; MRXQ1077; MRXQ1170.

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 JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE 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
    1180
  • Date
    2012-09-14
  • 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
    Reports of air or gas embolism were reported that occurred in association with the use of spray devices with a pressure regulator to administer EVICEL®. These events appear to be related to the use of the spray device at pressures higher than recommended and / or application closer to the tissue surface than recommended. The risk of air or gas embolism is an identified hazard for all fibrin sealants using air or pressurized gas for product application. To date, there have been no reports of adverse events of air or gas embolism when the spray application technique was used in accordance with the pressure and distance recommendations reported in the product's Instructions for Use (IFU). There are no notification records in the NOTIVISA system. Anvisa follows this Field Action.
  • Cause
    Risk of airborne embolism resulting in shock, hypertension, neurological deficit, cardiac arrest, and death if instructions for use are not followed or if pressure is applied at a greater or greater distance than recommended.
  • Action
    The company recommends the use of CO2 (where possible) as the gas for spray application, as it is more soluble in the blood and has the potential to reduce the damage associated with gas embolism. It is not contraindicating the use of air, since the product can be used with air when the indications of distance and pressure are observed correctly. End-expiratory blood pressure, pulse, oxygen saturation and CO2 should be monitored closely when applying EVICEL® because of the possibility of air or gas embolism. When using accessory tips for laparoscopic surgical procedures in conjunction with EVICEL®, tip tips should be followed for distance and pressure. For customers who confirm the use of one or more Omrix Pressure Regulators at their facility: Fill out the attached business response card and return it to us so we can send a package containing a label and instructions on how to place the label on the Regulator ( ) of Pressure. This label will be a reminder at the point of use on the correct pressure range for EVICEL®.

Device

PRESSURE REGULATOR FOR OMRIX APPLICATION DEVICE - Registration 80145909027 - QPR6: MRXQ0053; MRXQ...

Manufacturer

JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA