Events

Alerta De Seguridad para Articulated Cannulas Aortic Sarns (Sarns Aortic Arch Cannulae) with 3/8-inch connectors: (1) 6.5 mm, (2) 8 mm 24 Fr Flexible, (3) 6.5 mm 20 Fr High Flow with Suture Flange and Luer Port, (4) 24 Fr Flexible reinforced wire with Luer Port (Wire-Reinforced Flex with Luer Port); (5) 24 Fr Sarns Flexible Cannulae NW-Soft Flexible Articular Cannulae with Vented Cap Markings with Vented Cap, Luer Port, and 3/8-inch Connector. In the Catalog: (1) 98-0702-0710-9, (2) 4335, (3) 15495, (4) 98-0702-1447-7, (5) 98-0702-1286-9; Lots Nos .: (1) W507618; (2) W50743, 236511; (3) 236148, 238279, 241991; (4) W507617; (5) W507538, 236153

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Terumo Cardiovascular Systems Corp Div Terumo Medical Corp.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    178
  • Fecha
    2001-03-06
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    BRAZIL - 08/11/2001 - TERUMO MEDICAL COMPANY OF BRAZIL, INFORMES THAT THE PROVIDENCIES OF TRACKING THE INDICATED PRODUCTS AND IT WAS DETECTED ONLY ONE DISTRIBUTOR WITH ONE ITEM, AND CLARES THAT THOUGH THE IMPORTED PRODUCT CODE WAS EVEN IN THE RECALL LIST , THE SAME DOES NOT OCCUR WITH THE LOT NUMBER. THEREFORE, IT HAS NOT IN BRAZIL NO PRODUCT OF THAT PASSIVEL NUMBER OF RECALL NEEDS. INFORMS THAT YOU TRANSLATED THE LETTER RECALL AND REPAYED TO THE DISTRIBUTOR, AND THAT ALL THE NECESSARY MEASURES WERE TAKEN TO YOUR CUSTOMER TO ENSURE THE QUALITY OF THE PRODUCT.
  • Causa
    There may be a crack in the connector near the junction between the connector and the cannula tube in the aforementioned batches of the product. the crack in the connector can cause air to enter the perfusion circuit under low or no flow conditions, which may necessitate surgical replacement of the cannula.
  • Acción
    Make sure you have received the letter of March 6, 2001 from Terumo Cardiovascular Systems. Identify, isolate, and immediately stop using any affected product in your stock. To obtain a Product Return Authorization, number and return the affected products to Terumo Cardiovascular Systems. P to receive credit or exchange, contact your customer service representative at tel. (800) 521-2818 within the US, or your local Terumo sales representative outside the US. For more information, contact Brian Dawson, Terumo Cardiovascular Systems, at (800) 238-7866, ext. 6066, within the US, or tel. (734) 663-4145 outside the US.

Device

Articulated Cannulas Aortic Sarns (Sarns Aortic Arch Cannulae) with 3/8-inch connectors: (1) 6.5 ...

Manufacturer

Terumo Cardiovascular Systems Corp Div Terumo Medical Corp
  • Source
    ANVSANVISA