Alerta De Seguridad para AMS 800 URINARY CONTROL DEVICE. Anvisa Record: 80219980027. Model: Standard Control Pump (72400098). Products affected: units produced from November 4, 1997 until April 27, 2011.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AMS American Medical Systems Prod. Urinários e Ginecológicos Ltda..

¿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
    1061
  • Fecha
    2011-06-20
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    According to the company, the following events contributed to this action: (1) Following the introduction of a valve block component replacement mold of the AMS 800 Standard Control Pump, the AMS identified inconsistency between molds. Research on inconsistencies revealed that the previous mold (used since 1997) did not produce parts according to the design of released components. The use of the new locking valve mold resulted in a lower average activation pressure than the previous mold; (2) It was observed by the company that the operators on the shop floor were holding the control pump down during the end of functional tests to improve the alignment of the plunger in the test device used to measure the force required to activate the pump with the pump seat, which was not included as part of the approved test procedure; and (3) Issues resulting from the above would normally be mitigated by the final functional test performed on each unit produced as part of the normal manufacturing process. However, on April 27, 2011, calibration results showed readings that did not meet the requirement for accuracy, which led AMS to choose to collect the product. The potentially affected devices are therefore all units produced from November 4, 1997 to April 27, 2011. #### Update (08/11/2011): The company forwarded to the UTVIG copies of the invoices (for products collected) for destruction. Alert closed.
  • Causa
    Components of the equipment may have been produced that are not in accordance with the product specifications.
  • Acción
    Distributors and users of the product shall locate and segregate affected products, identifying them to prevent misuse. After identifying and segregating the affected products, distributors and users should contact the record holder to inform them of the location of the product. The record holder has already initiated a collection action for this case.